Review Panel
Clinical Chemistry FDA 510(k) Clearances & Devices
- Cleared Devices
- 13,065
- Product Codes (page)
- 44
- Latest Decision
- 2017-10-13
Clearances · page 7 of 131
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K170232 | AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer | Boditech Med, Inc. | JLW | Class II | 2017-10-13 |
| K170241 | GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System | All Medicus Co., Ltd. | NBW | Class II | 2017-10-13 |
| K170079 | Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System | Tyson Bioresearch, Inc. | NBW | Class II | 2017-10-06 |
| K170264 | Gold AQ Blood Glucose Monitoring System | Changsha Sinocare, Inc. | NBW | Class II | 2017-10-05 |
| K171941 | FreeStyle Precision Neo Blood Glucose Test Strips | Abbott Diabetes Care, Inc. | NBW | Class II | 2017-09-27 |
| K170118 | Scanostics UTI Check Application Test System | Teco Diagnostics | JMT | Class I | 2017-09-21 |
| K163462 | AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX | Radiometer Medical Aps | JHX | Class II | 2017-09-21 |
| K171822 | NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) | Biotest Medical Corporation | NBW | Class II | 2017-09-20 |
| K163433 | VITROS Chemistry Products GLU Slides | Ortho Clinical Diagnostics | CGA | Class II | 2017-09-18 |
| K170231 | iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5) | Andon Health Co, Ltd. | NBW | Class II | 2017-09-15 |
| K171785 | WowGoHealth Blood Glucose Monitoring System | Biotest Medical Corporation | NBW | Class II | 2017-09-15 |
| K171537 | CAPI 3 Hb A1c | Sebia | PDJ | Class II | 2017-09-12 |
| K163418 | Diazyme DZ-Lite Total beta-hCG Test System | Diazyme Laboratories | DHA | Class II | 2017-08-18 |
| K161679 | s LDL-EX SEIKEN | Denka Seiken Co., Ltd. | PYP | Class I | 2017-08-18 |
| K170064 | GLUCOCARD W Blood Glucose Monitoring System | Arkray Factory, Inc. | NBW | Class II | 2017-08-16 |
| K171103 | Lumipulse G TSH-III Immunoreaction Cartridges | Fujirebio Diagnostics,Inc. | JLW | Class II | 2017-07-28 |
| K161527 | Teco Creatinine Enzymatic Reagent Kit | Teco Diagnostics, Inc. | JFY | Class II | 2017-07-21 |
| K163159 | Dario Blood Glucose Monitoring System | Labstyle Innovations, Ltd. | NBW | Class II | 2017-07-19 |
| K162698 | MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer | Shenzhen New Industries Biomedical Engineering Co., Ltd. | JLW | Class II | 2017-07-14 |
| K163406 | Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System | ACON Laboratories, Inc. | CHH | Class I | 2017-07-11 |
| K171401 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 | Elitechgroup | CIG | Class II | 2017-07-11 |
| K170143 | GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, | Bionime Corporation | NBW | Class II | 2017-07-06 |
| K170587 | On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis | ACON Laboratories, Inc. | JIN | Class I | 2017-07-06 |
| K162822 | ADAMS A1c HA-8180V, CALIBRATOR 80 | Arkray Factory, Inc. | PDJ | Class II | 2017-06-29 |
| K162723 | TransFix/EDTA Vacuum Blood Collection Tubes | Caltag Medsystems, Ltd. | GIM | Class II | 2017-06-22 |
| K163652 | ePlex Instrument | Genmark Diagnostics, Incorporated | NSU | Class II | 2017-06-09 |
| K162564 | Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System | Tianjin Empecs Medical Device Co., Ltd. | NBW | Class II | 2017-06-07 |
| K170200 | Carbon Dioxide Reagent Set | Teco Diagnostics, Inc. | KHS | Class II | 2017-06-01 |
| K162526 | Creatine Kinase-MB | Roche Diagnostics | JHW | Class II | 2017-05-26 |
| K171059 | Nova StatSensor Creatinine Hospital Meter System | Nova Biomedical Corporation | CGL | Class II | 2017-05-26 |
| K170558 | revogene | Genepoc, Inc. | OOI | Class II | 2017-05-25 |
| K163658 | ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay | Siemens Healthcare Diagnostics, Inc. | CEW | Class II | 2017-05-23 |
| K163073 | Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder | Sol-Millennium Medical, Inc. | JKA | Class II | 2017-05-19 |
| DEN170019 | Vitamin D 200M Assay for the Topaz System | Ab Sciex, LLC | PSL | Class II | 2017-05-18 |
| K171168 | VITROS Immunodiagnostic Products Insulin Calibrators | Ortho Clinical Diagnostics | JIT | Class II | 2017-05-16 |
| K171072 | N Latex Cystatin C; N Protein Standard UY | Siemens Healthcare Diagnostics Products GmbH | NDY | Class II | 2017-05-12 |
| K171083 | iChemVELOCITY Automated Urine Chemistry System | Iris Diagnostics, A Division of Iris International, Inc. | JIL | Class II | 2017-05-12 |
| K171080 | ALP IFCC Gen.2 | Roche Diagnostics Operations (Rdo) | CJE | Class II | 2017-05-10 |
| K161790 | iGlucose Blood Glucose Monitoring System | Bionime Corporation | NBW | Class II | 2017-05-02 |
| K162200 | Randox RX Daytona Plus Magnesium (MG) | Randox Laboratories, Ltd. | JGJ | Class I | 2017-04-28 |
| K170882 | ABL90 FLEX, ABL90 FLEX PLUS | Radiometer Medical Aps | MQM | Class I | 2017-04-28 |
| K170938 | CalSet IGF-1 | Roche Diagnostics | JIT | Class II | 2017-04-26 |
| K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP) | Randox Laboratories Limited | CJE | Class II | 2017-04-21 |
| K160179 | VivaChek Ino Blood Glucose Monitoring System | Vivachek Laboratories, Inc. | NBW | Class II | 2017-04-21 |
| K162382 | Smart Dongle Blood Glucose Monitoring System | Taidoc Technology Corporation | NBW | Class II | 2017-04-14 |
| K160990 | Nova Max Uric Acid Monitoring System | Nova Biomedical Corporation | PTC | Class I | 2017-04-11 |
| K163271 | i-Stat Alinity System with i-Stat Glucose test | Abbott Point of Care, Inc. | CGA | Class II | 2017-04-10 |
| K162203 | POGO Automatic Blood Glucose Monitoring System | Intuity Medical, Inc. | NBW | Class II | 2017-04-06 |
| K170678 | Beta-CrossLaps CalCheck 5 | Roche Diagnostics | JJX | Class I | 2017-04-04 |
| K162530 | Multichem IA Plus | Techno-Path Manufacturing | JJY | Class I | 2017-03-31 |
| K152534 | Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System | Tianjin Empecs Medical Device Co., Ltd. | NBW | Class II | 2017-03-21 |
| K161691 | Direct LDL Cholesterol (LDL) | Randox Laboratories Limited | MRR | Class I | 2017-03-20 |
| K162298 | LOCI Total Vitamin D Total Assay, LOCI VITD CAL | Siemens Healthcare Diagnostics | MRG | Class II | 2017-03-16 |
| K163629 | Audit MicroControls Linearity FD Tumor Markers II | Aalto Scientific, Ltd. | JJY | Class I | 2017-03-10 |
| K161954 | Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) | Siemens Healthcare Diagnostics | JGS | Class II | 2017-03-09 |
| K170065 | ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) | Siemens Healthcare Diagnostics, Inc. | JFM | Class II | 2017-03-09 |
| K170267 | BGM009 Plus Blood Glucose Monitoring System | Apex BioTechnology Corp. | NBW | Class II | 2017-03-09 |
| K161521 | TAP Blood Collection Device | Seventh Sense Biosystems, Inc. | PRJ | Class II | 2017-02-16 |
| K153561 | AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System | Andon Health Co, Ltd. | NBW | Class II | 2017-02-16 |
| K170160 | Abbott ARCHITECT Free T3 | Abbott Laboratories | JIT | Class II | 2017-02-15 |
| K163508 | PIVO | Velano Vascular | JKA | Class II | 2017-02-09 |
| K170091 | UA-Cellular Complete | Streck | JJW | Class I | 2017-02-09 |
| K162840 | Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 | Roche Diagnostics | MRG | Class II | 2017-02-08 |
| DEN150035 | SEEKER System | Baebies, Inc. | PQW | Class II | 2017-02-03 |
| K161158 | IDS-iSYS Intact PTHN | Immunodiagnostic Systems , Ltd. | CEW | Class II | 2017-01-31 |
| K162606 | Elecsys TSH assay, cobas e 801 Immunoassay analyzer | Roche Diagnostics | JLW | Class II | 2017-01-23 |
| K162399 | Atellica CH Magnesium (Mg) | Siemens Healthcare Diagnostics, Inc. | JGJ | Class I | 2017-01-19 |
| K162430 | UniStrip1 Generic Blood Glucose Test Strips | Ok Biotech Co., Ltd. | NBW | Class II | 2017-01-19 |
| K162895 | Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 | Roche Diagnostics | MMI | Class II | 2017-01-18 |
| K163546 | Lumipulse G Progesterone-N Calibrators | Fujirebio Diagnostics,Inc. | JIT | Class II | 2017-01-13 |
| K163534 | Lumipulse G FSH-N Calibrators | Fujirebio Diagnostics,Inc. | JIT | Class II | 2017-01-13 |
| K163521 | Lumipulse G LH Calibrators | Fujirebio Diagnostics,Inc. | JIT | Class II | 2017-01-12 |
| K163544 | Lumipulse G Prolactin | Fujirebio Diagnostics,Inc. | JIT | Class II | 2017-01-12 |
| K162173 | Elecsys CYFRA 21-1 CalCheck 5 | Roche Diagnostics | JJX | Class I | 2017-01-12 |
| K162336 | Contour Next EZ Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | NBW | Class II | 2017-01-12 |
| K162754 | FREND Vitamin D Test System | Nanoentek USA, Inc. | MRG | Class II | 2017-01-12 |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak | Bio-Rad Laboratories | JJY | Class I | 2017-01-10 |
| K163490 | StatStrip Xpress 2 Glucose Hospital Meter System | Nova Biomedical Corporation | PZI | Class II | 2017-01-06 |
| K162233 | Kurin Blood Culture Collection Set | Pathway, LLC | JKA | Class II | 2016-12-23 |
| K161299 | BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System | Apex BioTechnology Corp. | NBW | Class II | 2016-12-23 |
| K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System | Polymer Technology Systems, Inc. | CHH | Class I | 2016-12-22 |
| K162282 | CardioChek Plus Test System, CardioChek Home Test System | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | CGA | Class II | 2016-12-22 |
| K160571 | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay | Roche Diagnostics Operations (Rdo) | PDJ | Class II | 2016-12-19 |
| DEN150057 | Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 | Roche Diagnostics | PQO | Class II | 2016-12-19 |
| K160742 | NoCoding1 Plus Blood Glucose Monitoring System | I-Sens, Inc. | NBW | Class II | 2016-12-16 |
| K162020 | VITROS Chemistry Products Cl- Slides | Ortho Clinical Diagnostics | CGZ | Class II | 2016-12-16 |
| K161837 | ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer | Beckman Coulter, Inc. | JGS | Class II | 2016-12-16 |
| K160402 | GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) | Instrumentation Laboratory CO | CGA | Class II | 2016-12-14 |
| K160225 | GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator | Instrumentation Laboratory CO | JGS | Class II | 2016-12-14 |
| K160412 | GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) | Instrumentation Laboratory CO | CHL | Class II | 2016-12-14 |
| K163078 | DC-UIBC-CAL | Sekisui Diagnostics P.E.I., Inc. | JIT | Class II | 2016-12-08 |
| K163053 | Lumipulse G E2-III Calibrators | Fujirebio Diagnostics,Inc. | JIT | Class II | 2016-12-01 |
| K152327 | EasyLyte Na/K/Cl/Ca Analyzer | Medica Corporation | JFP | Class II | 2016-12-01 |
| K161834 | One Drop Blood Glucose Monitoring System | Agamatrix, Inc. | NBW | Class II | 2016-11-30 |
| K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator | Siemens Healthcare Diagnostics | JIT | Class II | 2016-11-17 |
| K160682 | CONTOUR NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | NBW | Class II | 2016-11-17 |
| K161831 | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set | Immunodiagnostic Systems , Ltd. | MRG | Class II | 2016-11-15 |
| K161494 | Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) | Siemens Healthcare Diagnostics, Inc. | CGX | Class II | 2016-11-15 |
| K161856 | StatStrip Xpress Glucose Hospital Meter System | Nova Biomedical Corporation | PZI | Class II | 2016-11-15 |
| K161738 | FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems | Taidoc Technology Corporation | NBW | Class II | 2016-11-10 |
13,065 clearances in the Clinical Chemistry panel. Data: openFDA.