Review Panel
Clinical Chemistry FDA 510(k) Clearances & Devices
- Cleared Devices
- 13,065
- Product Codes (page)
- 39
- Latest Decision
- 2015-09-24
Clearances · page 9 of 131
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K151786 | Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet | Roche Diagnostics | CDD | Class II | 2015-09-24 |
| K151742 | Contour Next Control Solution | Bayer Healthcare | JJX | Class I | 2015-09-23 |
| K143720 | Dimension Vista MMB Assay | Siemens Healthcare Diagnostics | JHY | Class II | 2015-09-18 |
| K152328 | FreeStyle InsuLinx Blood Glucose Monotioring System | Abott Laboratories | LFR | Class II | 2015-09-17 |
| K151982 | Stat Profile Prime ABG Analyzer System | Nova Biomedical Corporation | CHL | Class II | 2015-09-10 |
| K142821 | PAXgene Blood DNA Tube | Preanalytix GmbH | PJE | Class II | 2015-09-09 |
| K151595 | On Call Express Pro Blood Glucose Monitoring System | ACON Laboratories, Inc. | NBW | Class II | 2015-09-05 |
| K150274 | GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System | Infopia Co, Ltd. | NBW | Class II | 2015-08-26 |
| K142351 | 25-Hydroxy Vitamin Ds EIA | Immunodiagnostic Systems , Ltd. | MRG | Class II | 2015-08-25 |
| K151164 | Assure Prism multi Blood Glucose Monitoring System | I-Sens, Inc. | NBW | Class II | 2015-08-07 |
| K150022 | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream | Guangzhou Wondfo Biotech Co., Ltd. | LCX | Class II | 2015-08-07 |
| K142689 | GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System | Apex BioTechnology Corp. | CGA | Class II | 2015-08-06 |
| K151856 | ABL80 FLEX CO-OX with AQURE connectivity | Sendx Medical, Inc. | CHL | Class II | 2015-08-06 |
| K150819 | Triglycerides | Randox Laboratories Limited | CDT | Class I | 2015-08-06 |
| K132929 | SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM | Sd Biosensor, Inc. | NBW | Class II | 2015-08-05 |
| K150214 | OneTouch Verio Flex Blood Glucose Monitoring System | Lifescan Europe | NBW | Class II | 2015-07-31 |
| K141289 | TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS | Teco Diagnostics | JIL | Class II | 2015-07-24 |
| K151113 | ELITech Clinical Systems CALCIUM ARSENAZO | Elitechgroup | CJY | Class II | 2015-07-22 |
| K143687 | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material | Siemens Healthcare Diagnostics, Inc. | JJX | Class I | 2015-07-17 |
| K151690 | Alere i Instrument, Alere i Influenza A & B, Alere i Strep A | Alere Scarborough, Inc. | OOI | Class II | 2015-07-16 |
| K151566 | Abbott ARCHITECT Total T4 Calibrators | Abbott Laboratories | JIT | Class II | 2015-07-10 |
| K151552 | ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II | Elitechgroup | JIX | Class II | 2015-07-08 |
| K151530 | CardioChek Plus Test System | Polymer Technology Systems, Inc. | CGA | Class II | 2015-07-07 |
| K143075 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set | Tosoh Bioscience, Inc. | CDZ | Class I | 2015-07-02 |
| K150879 | LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers | DiaSorin, Inc. | CEW | Class II | 2015-06-22 |
| K142898 | ABL800 FLEX with AQURE connectivity | Radiometer Medical Aps | CHL | Class II | 2015-06-17 |
| K140790 | Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) | Siemens Healthcare Diagnostics | JIX | Class II | 2015-06-15 |
| K141292 | Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System | Bionime Coporation | NBW | Class II | 2015-06-09 |
| K132058 | VIDAS FT4 | Biomerieux S.A. | CEC | Class II | 2015-06-08 |
| K150531 | FreeStyle Freedom Lite Blood Glucose Monitoring System | Abbott Laboratories | NBW | Class II | 2015-06-05 |
| K150332 | FreeStyle Lite Blood Glucose Monitoring System | Abbott Laboratories | NBW | Class II | 2015-06-05 |
| K142595 | VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II | Ortho Clinical Diagnostics | PDJ | Class II | 2015-06-04 |
| K143387 | GE333 Blood Glucose Monitoring System | Bionime Coporation | NBW | Class II | 2015-06-03 |
| K141907 | STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A | Nova Biomedical Corporation | CHL | Class II | 2015-05-29 |
| K141874 | URISCAN OPTIMA | Yd Diagnostics Corp. | KQO | Class I | 2015-05-28 |
| K140068 | CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM | Polymer Technology Systems, Inc. | NBW | Class II | 2015-05-22 |
| K140654 | Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls | Abbott Laboratories | PDJ | Class II | 2015-05-22 |
| K150461 | StatStrip Xpress Glucose Hospital Meter System | Nova Biomedical Corporation | PZI | Class II | 2015-05-20 |
| K151236 | MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal) | Medtronic Minimed, Inc. | PJT | Class II | 2015-05-19 |
| K141351 | SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM | Biotest Medical Corp. | NBW | Class II | 2015-05-19 |
| K140150 | Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30 | Hmd Biomedical, Inc. | NBW | Class II | 2015-05-14 |
| K150226 | Hematocrit and Metabolite QUALICHECK | Radiometer Medical Aps | JJS | Class I | 2015-05-13 |
| K142543 | Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control | ACON Laboratories, Inc. | KQO | Class I | 2015-05-11 |
| K143750 | MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System | Apex BioTechnology Corp. | CGA | Class II | 2015-05-07 |
| K143467 | FORA GD43 Blood Glucose Monitoring System | Taidoc Technology Corporation | NBW | Class II | 2015-05-07 |
| K150281 | StatStrip Glucose Hospital Meter | Nova Biomedical Corporation | PZI | Class II | 2015-05-06 |
| K141036 | BGM009 BLOOD GLUCOSE MONITORING SYSTEM | Apex BioTechnology Corp. | NBW | Class II | 2015-05-01 |
| K150403 | ADVIA Centaur TSH3-Ultra | Siemens Healthcare Diagnostics, Inc. | JLW | Class II | 2015-05-01 |
| K150955 | Elecsys Progesterone III Cal Check 5 | Roche Diagnostics | JJX | Class I | 2015-05-01 |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test Kit | Maine Standards Company, LLC | JJY | Class I | 2015-04-30 |
| K150330 | Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) | ACON Laboratories, Inc. | JIR | Class I | 2015-04-30 |
| K141999 | ADVIA CENTAUR TSH | Siemens Healthcare Diagnostics, Inc. | JLW | Class II | 2015-04-22 |
| K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers | Immunodiagnostic Systems , Ltd. | CJM | Class II | 2015-04-21 |
| K132663 | I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM | Alliance International Co., Ltd. | NBW | Class II | 2015-04-20 |
| K133002 | i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials | Abbott Point of Care, Inc. | DHA | Class II | 2015-04-16 |
| K141914 | PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM | Ok Biotech Co., Ltd. | NBW | Class II | 2015-04-15 |
| K150132 | IMMULITE IGF Control Module, IMMULITE Gastrin Control Module | Siemens Healthcare Diagnostics | JJX | Class I | 2015-04-13 |
| K142262 | AUTION CHECK PLUS | Quantimetrix Corp. | JJW | Class I | 2015-04-10 |
| K150510 | Total Bilirubin | Abbott Laboratories | CIG | Class II | 2015-04-02 |
| K142723 | ADVIA Centaur Cortisol (COR) Assy | Siemens Healthcare Diagnostics, Inc. | JFT | Class II | 2015-03-31 |
| K143324 | IDS-iSYS CTX-I Calibration Verifiers | Immunodiagnostic Systems , Ltd. | JJX | Class I | 2015-03-30 |
| K150052 | TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System | Nipro Diagnostics, Inc. | NBW | Class II | 2015-03-26 |
| K142448 | VARIANT II TURBO HbA1c Kit - 2.0 | Bio-Rad Laboratories, Inc. | PDJ | Class II | 2015-03-24 |
| K143379 | Liquichek Maternal Serum II Control | Bio-Rad Laboratories | JJY | Class I | 2015-03-13 |
| K141867 | ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM | Roche Diagnostics | NBW | Class II | 2015-03-03 |
| K143373 | IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | JJX | Class I | 2015-02-26 |
| K142985 | UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator | Beckman Coulter, Inc. | JIT | Class II | 2015-02-26 |
| K143636 | IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | JJX | Class I | 2015-02-25 |
| K141410 | ORAGENE DX OGD-500.001 | DNA Genotek, Inc. | OYJ | Class II | 2015-02-19 |
| K143178 | FilmArray 2.0 System | Biofire Diagnostics, LLC | NSU | Class II | 2015-01-30 |
| K143691 | LDLC3 LDL-Cholesterol Gen.3 | Roche Diagnostics Operations (Rdo) | LBR | Class I | 2015-01-28 |
| K143680 | ADVIA Centaur IgE Master Curve Material | Siemens Healthcare Diagnostics, Inc. | JJX | Class I | 2015-01-27 |
| DEN140038 | Dexcom Share Direct Secondary Displays | Dexcom, Inc. | PJT | Class II | 2015-01-23 |
| K143571 | Audit MicroControls Linearity LQ Cystatin-C | Aalto Scientific, Ltd. | JJX | Class I | 2015-01-23 |
| K143639 | IMMULITE 2000 CEA Calibration Verification Material | Siemens Healthcare Diagnostics | JJX | Class I | 2015-01-23 |
| K143573 | Audit MicroControls Linearity FD Tumor Markers II | Aalto Scientific, Ltd. | JJY | Class I | 2015-01-16 |
| K143504 | IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | JJX | Class I | 2015-01-14 |
| K141114 | BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D | Bio-Rad Laboratories | MRG | Class II | 2015-01-09 |
| K142946 | TIVA | Velano Vascular, Inc. | JKA | Class II | 2015-01-08 |
| K143352 | IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | JJX | Class I | 2014-12-24 |
| K140436 | ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS | Fujirebio Diagnostics,Inc. | OSX | Class II | 2014-12-23 |
| K143376 | ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material | Siemens Healthcare Diagnostics, Inc. | JJX | Class I | 2014-12-23 |
| K142391 | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) | ACON Laboratories, Inc. | JFY | Class II | 2014-12-22 |
| K142373 | Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst | Beckman Coulter, Inc. | MRG | Class II | 2014-12-22 |
| K142362 | Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno. | Beckman Coulter, Inc. | MRG | Class II | 2014-12-19 |
| K143342 | Elecsys T-Uptake Calset | Roche Diagnostics | JIT | Class II | 2014-12-19 |
| K140554 | IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET | Immunodiagnostic Systems , Ltd. | MRG | Class II | 2014-12-19 |
| K142089 | ACCU-CHEK AVIVA EXPERT SYSTEM | Roche Diagnostics Corporation | LFR | Class II | 2014-12-17 |
| K143296 | AIA-PACK C-Peptide Control Set | Tosoh Bioscience, Inc. | JJX | Class I | 2014-12-16 |
| K143284 | Elecsys Estradiol III Calcheck | Roche Diagnostics | JJX | Class I | 2014-12-16 |
| K141463 | LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS | DiaSorin, Inc. | MRG | Class II | 2014-12-10 |
| K141925 | TOTAL PROTEIN URINE/CSF GEN.3 | Roche Diagnostics Operations (Rdo) | JIQ | Class I | 2014-12-09 |
| K140971 | LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. | Randox Laboratories Limited | JJY | Class I | 2014-12-08 |
| K143194 | ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM) | Siemens Healthcare Diagnostics, Inc. | JJX | Class I | 2014-12-05 |
| K143144 | ST AIA-PACK PROG II Calibrator Set | Tosoh Bioscience, Inc. | JIT | Class II | 2014-12-03 |
| K141862 | HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE | H2, Inc. | NBW | Class II | 2014-12-02 |
| K140842 | DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART | Siemens Healthcare Diagnostics, Inc. | CEC | Class II | 2014-11-26 |
| K140859 | DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT | Siemens Healthcare Diagnostics, Inc. | CEC | Class II | 2014-11-26 |
| K143026 | Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity | Aalto Scientific, Ltd. | JJX | Class I | 2014-11-21 |
| K142978 | Audit MicroControls Linearity LQ Special Diabetes | Aalto Scientific, Ltd. | JJY | Class I | 2014-11-20 |
13,065 clearances in the Clinical Chemistry panel. Data: openFDA.