Review Panel
Clinical Chemistry FDA 510(k) Clearances & Devices
- Cleared Devices
- 13,065
- Product Codes (page)
- 37
- Latest Decision
- 2016-11-04
Clearances · page 8 of 131
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K160153 | ABL90 FLEX PLUS | Radiometer Medical Aps | CHL | Class II | 2016-11-04 |
| K161646 | Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set | Diazyme Laboratories | CGN | Class II | 2016-11-04 |
| K162514 | Multichem A1c | Technopath Manufacturing | JJX | Class I | 2016-10-26 |
| K160541 | Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control | Sysmex America, Inc. | JLW | Class II | 2016-10-21 |
| K162593 | HDL-Cholesterol Gen.4 | Roche Diagnostics Operations (Rdo) | LBS | Class I | 2016-10-19 |
| K160495 | VITROS® Automation Solutions | Ortho-Clinical Diagnostics, Inc. | KLI | Class II | 2016-10-18 |
| K161687 | D-10 Hemoglobin A1c Program | Bio-Rad Laboratories, Inc. | PDJ | Class II | 2016-10-14 |
| K153577 | FREND Testosterone Test System | Nanoentek USA, Inc. | CDZ | Class I | 2016-10-14 |
| K160062 | AUTION ELEVEN Semi-Automated Urinalysis System | Arkray, Inc. | JIL | Class II | 2016-10-07 |
| K160365 | BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System | Infopia Co, Ltd. | NBW | Class II | 2016-09-28 |
| K160657 | BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube | Becton, Dickinson and Company | JKA | Class II | 2016-09-23 |
| K161721 | Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set | Diazyme Laboratories | CDD | Class II | 2016-09-20 |
| K161818 | GEM Premier 3000 | Instrumentation Laboratory CO | CGA | Class II | 2016-09-14 |
| K153644 | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II | Elitechgroup | CFR | Class II | 2016-09-07 |
| K160724 | ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator | Siemens Healthcare Diagnostics, Inc. | CGS | Class II | 2016-09-07 |
| K160944 | ACCU-CHEK Guide Blood Glucose Monitoring System | Roche Diabetes Care, Inc. | NBW | Class II | 2016-08-31 |
| K153286 | iHealth Align Gluco-Monitoring system | Andon Health Co, Ltd. | NBW | Class II | 2016-08-19 |
| K153278 | Wireless Smart Gluco-Monitoring System | Andon Health Co, Ltd. | NBW | Class II | 2016-08-19 |
| K153651 | Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems | Beckman Coulter, Inc. | JLW | Class II | 2016-08-18 |
| K153375 | ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls | Abbott Laboratories | MRG | Class II | 2016-08-12 |
| K161874 | Audit MicroControls Linearity DROP LQ Blood Glucose | Aalto Scientific, Ltd. | JJX | Class I | 2016-08-10 |
| K161867 | On Call Pro Blood Glucose Monitoring System | Acon Laboratories | NBW | Class II | 2016-08-05 |
| K160038 | UniStrip1 Generic Blood Glucose Test Strips | Ok Biotech Co., Ltd. | NBW | Class II | 2016-07-29 |
| K161817 | Tina-quant Cystatin C Gen.2 | Roche Diagnostics Operations (Rdo) | NDY | Class II | 2016-07-27 |
| K160757 | ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) | Axis-Shield Diagnostics Limited | CDD | Class II | 2016-07-26 |
| K160372 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | Teco Diagnostics, Inc. | JIL | Class II | 2016-07-22 |
| K152599 | PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System | Ok Biotech Co., Ltd. | NBW | Class II | 2016-07-20 |
| K151978 | EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control | Edan Instruments, Inc. | CHL | Class II | 2016-07-15 |
| K153357 | i-STAT Alinity System with i-STAT Sodium test | Abbott Point of Care, Inc. | JGS | Class II | 2016-07-08 |
| K161526 | LIAISON CMV IgM Serum Control Set | DiaSorin, Inc. | JJX | Class I | 2016-06-30 |
| K161522 | LIAISON EBV IgM Serum Control Set | DiaSorin, Inc. | JJX | Class I | 2016-06-30 |
| K161495 | ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) | Luminex Corporation | OOI | Class II | 2016-06-30 |
| K151986 | ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material | Siemens Healthcare Diagnostics, Inc. | CDZ | Class I | 2016-06-29 |
| K160430 | Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | NBW | Class II | 2016-06-24 |
| K153692 | Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer | Infrared Laboratory Systems, LLC (Dba Synermed) | CGA | Class II | 2016-06-24 |
| K153201 | SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System | Sd Biosensor | NBW | Class II | 2016-06-24 |
| K160156 | StatStrip Xpress Blood Glucose Monitoring System | Nova Biomedical Corporation | NBW | Class II | 2016-06-23 |
| K160370 | BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | JGS | Class II | 2016-06-09 |
| K153165 | NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit | Astute Medical, Inc. | PIG | Class II | 2016-06-01 |
| K160647 | IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 | Siemens Healthcare Diagnostics, Inc. | JLW | Class II | 2016-05-31 |
| K152556 | Oragene Dx | DNA Genotek, Inc. | OYJ | Class II | 2016-05-26 |
| K152464 | ORAcollect.Dx | DNA Genotek, Inc. | OYJ | Class II | 2016-05-26 |
| K160570 | Creatine Kinase | Roche Diagnostics Operations (Rdo) | JHS | Class II | 2016-05-25 |
| K161140 | VITROS Chemistry Products Calibrator Kit 3 | Ortho-Clinical Diagnostics, Inc. | JIX | Class II | 2016-05-20 |
| K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers | Immunodiagnostic Systems , Ltd. | JJX | Class I | 2016-05-17 |
| K152227 | Elecsys Cortisol II, Cortisol II CalSet | Roche Diagnostics | JFT | Class II | 2016-04-27 |
| K152493 | POGO Automatic Blood Glucose Monitoring System | Intuity Medical, Inc. | NBW | Class II | 2016-04-25 |
| K152553 | CueSee Hypoxic | Eurotrol B.V. | JJS | Class I | 2016-04-22 |
| K152117 | Dropper hsCRP High Sensitivity CRP Control | Quantimetrix Corporation | JJX | Class I | 2016-04-21 |
| K152365 | AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System | Agamatrix, Inc. | NBW | Class II | 2016-04-21 |
| K153361 | Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators | Fujirebio Diagnostics,Inc. | MRG | Class II | 2016-04-15 |
| K160517 | ARIES System | Luminex Corporation | OOI | Class II | 2016-04-12 |
| K142754 | Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test | Sugentech, Inc. | LCX | Class II | 2016-04-07 |
| K143548 | TRUE METRIX GO Self Monitoring Blood Glucose System | Trividia Health, Inc. | NBW | Class II | 2016-04-01 |
| K152835 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | Teco Diagnostics, Inc. | JFY | Class II | 2016-03-07 |
| K152085 | Liquid CO2-2 (LCO2-2) | Randox Laboratories, Ltd. | KHS | Class II | 2016-02-24 |
| K152768 | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip | Assure Tech. Co., Ltd. | JHI | Class II | 2016-02-24 |
| K153330 | FreeStyle Precision Neo H Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | NBW | Class II | 2016-02-19 |
| K152422 | FREND Free T4 Test System | Nanoentek USA, Inc. | CEC | Class II | 2016-02-17 |
| K160113 | ST AIA-PACK hsE2 Calibrator Set | Tosoh Bioscience, Inc. | JIT | Class II | 2016-02-17 |
| K152343 | Direct Bilirubin | Randox Laboratories Limited | JFM | Class II | 2016-02-16 |
| K153309 | BD Vacutainer UltraTouch Push Button Blood Collection Set | Becton, Dickinson and Company | JKA | Class II | 2016-02-12 |
| K151529 | Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator | Siemens Healthcare Diagnostics, Inc. | CDZ | Class I | 2016-02-11 |
| K152185 | ARCHITECT SHBG | Biokit, S.A. | CDZ | Class I | 2016-02-11 |
| K152344 | Total Bilirubin | Randox Laboratories Limited | JFM | Class II | 2016-01-28 |
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit | Radiometer America, Inc. | JJY | Class I | 2016-01-28 |
| K152986 | StatStrip Xpress 2 Glucose Hospital Meter System | Nova Biomedical Corporation | PZI | Class II | 2016-01-27 |
| K151487 | Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method | Diatron U.S., Inc. | CFR | Class II | 2016-01-14 |
| K153435 | Direct HDL Cholesterol (HDL) | Randox Laboratories, Ltd. | LBS | Class I | 2016-01-08 |
| K143169 | MyGlucoHealth Wireless System | Entra Health Systems | NBW | Class II | 2016-01-08 |
| K152924 | TIVA¿ | Velano Vascular | JKA | Class II | 2016-01-07 |
| K150817 | Dario Blood Glucose Monitoring System | Labstyle Innovations, Ltd. | NBW | Class II | 2015-12-21 |
| K153417 | ST AIA-PACK PROG III Calibrator Set | Tosoh Bioscience, Inc. | JIT | Class II | 2015-12-18 |
| K153365 | ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator | Siemens Healthcare Diagnostics, Inc. | JIX | Class II | 2015-12-18 |
| K152155 | ARCHITECT 2nd Generation Testosterone | Abbott Laboratories | CDZ | Class I | 2015-12-17 |
| K142785 | PRODIGY iConnect Blood Glucose Monitoring System | Ok Biotech Co., Ltd. | NBW | Class II | 2015-12-17 |
| K152442 | Freestyle Freedom Blood Glucose Monitoring Sytem | Abbott Laboratories | NBW | Class II | 2015-12-17 |
| K151611 | OneTouch Ultra Plus Flex Blood Glucose Monitoring System | Lifescan Europe | NBW | Class II | 2015-12-14 |
| K151767 | Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator | Siemens Healthcare Diagnostics, Inc. | JGS | Class II | 2015-12-11 |
| K150300 | Liquichek Cardiac Markers Plus Control LT | Bio-Rad Laboratories | JJY | Class I | 2015-12-11 |
| K151321 | D-100 HbA1c, D-100 HbA1c Calibrator Pack | Bio-Rad Laboratories, Inc. | PDJ | Class II | 2015-12-09 |
| K151639 | ABL80 FLEX and ABL80 FLEX CO-OX | Sendx Medical, Inc. | CGA | Class II | 2015-12-07 |
| K150833 | iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System | Andon Health Co, Ltd. | NBW | Class II | 2015-12-04 |
| K151658 | Gmate Origin Blood Glucose Monitoring System | Philosys, Inc. | NBW | Class II | 2015-12-01 |
| K150942 | Contour Next USB Blood Glucose Monitoring System | Bayer Healthcare | NBW | Class II | 2015-11-25 |
| K150528 | Cortisol Saliva Luminescence Immunoassay | Ibl International GmbH | NHG | Class II | 2015-11-25 |
| K151265 | SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System | Sd Biosensor | NBW | Class II | 2015-11-24 |
| K151792 | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System | Siemens Healthcare Diagnostics, Inc. | JLW | Class II | 2015-11-20 |
| K150299 | Gmate SMART Blood Glucose Monitoring System | Philosys, Inc. | NBW | Class II | 2015-11-19 |
| K150168 | Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) | Siemens Healthcare Diagnostics | MLM | Class II | 2015-11-04 |
| K150270 | ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set | Tosoh Bioscience, Inc. | MRG | Class II | 2015-10-26 |
| K150396 | Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips | Apex BioTechnology Corp. | NBW | Class II | 2015-10-14 |
| K140325 | Joinsoon EON L Glucose Monitoring System and Joinsoon EON LS Glucose Monitoring System | Joinsoon Medical Technology Co, Ltd. | NBW | Class II | 2015-10-13 |
| K151917 | ARIES System | Luminex Corporation | OOI | Class II | 2015-10-06 |
| K150063 | One Step hCG Pregnancy Test | Coretests, Inc. | LCX | Class II | 2015-10-02 |
| K152526 | Elecsys Progesterone III CalSet | Roche Diagnostics | JIT | Class II | 2015-10-02 |
| K141656 | GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEM | Philosys, Inc. | NBW | Class II | 2015-10-02 |
| K142928 | FreeStyle Precision Neo Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | NBW | Class II | 2015-09-30 |
| K150654 | Cholesterol | Randox Laboratories, Ltd. | CHH | Class I | 2015-09-29 |
| K151100 | U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System | Taidoc Technology Corporation | NBW | Class II | 2015-09-29 |
13,065 clearances in the Clinical Chemistry panel. Data: openFDA.