Review Panel
Clinical Chemistry FDA 510(k) Clearances & Devices
- Cleared Devices
- 13,065
- Product Codes (page)
- 41
- Latest Decision
- 2023-10-18
Clearances · page 3 of 131
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K231826 | Omnipod 5 ACE Pump | Insulet Corporation | QFG | Class II | 2023-10-18 |
| K231824 | SmartBolus Calculator | Insulet Corporation | QRX | Class II | 2023-10-18 |
| K230741 | Macro & Micro-Test HCG Pregnancy Test Midstream | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | LCX | Class II | 2023-10-13 |
| K233044 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | QFG | Class II | 2023-10-05 |
| K232722 | endo.digital Platform | DreaMed Diabetes, Ltd. | QCC | Class II | 2023-10-03 |
| K221900 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | CHL | Class II | 2023-09-29 |
| K220458 | UltraFlo-R Push Button Blood Collection Set | Innovative Medical Technologies, Inc. | JKA | Class II | 2023-09-29 |
| K223085 | Miris Human Milk Analyzer (HMA) | Miris AB | QEI | Class II | 2023-09-29 |
| K230865 | PIVO Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. | JKA | Class II | 2023-09-28 |
| K220396 | EasyStat 300 | Medica Corporation | CEM | Class II | 2023-09-26 |
| K220265 | ADVIA Centaur® NT-proBNPII (PBNPII) | Siemens Healthcare Diagnostics, Inc. | NBC | Class II | 2023-09-24 |
| K221817 | ALFIS Vitamin D, ALFIS-3 Analyzer | Immunostics Inc., | MRG | Class II | 2023-09-22 |
| K232224 | iLet® Dosing Decision Software | Beta Bionics, Inc. | QJI | Class II | 2023-09-22 |
| K223179 | Cholestech LDX System | Alere San Diego, Inc. | CGA | Class II | 2023-09-20 |
| K223857 | i-STAT G3+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | CHL | Class II | 2023-09-15 |
| K223755 | i-STAT G cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | CGA | Class II | 2023-09-11 |
| K222921 | Minuteful-kidney test | Healthy.Io, Ltd. | JIR | Class I | 2023-09-08 |
| K230890 | ISE Electrodes | Randox Laboratories, Ltd. | CEM | Class II | 2023-09-08 |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent Pack | Ortho Clinical Diagnostics | CEW | Class II | 2023-09-05 |
| K213670 | BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes | Becton, Dickinson and Company | GIM | Class II | 2023-08-25 |
| K223590 | Access Folate Assay | Beckman Coulter, Inc. | CGN | Class II | 2023-08-23 |
| K223867 | IDS ACTH II | Immunodiagnostic Systems Limited | CKG | Class II | 2023-08-18 |
| K222888 | BlueStar CGM insulin dose calculator | Welldoc, Inc. | QRX | Class II | 2023-08-11 |
| K223608 | GEM Premier 7000 with IQM3 | Instrumentation Laboratory Company | CHL | Class II | 2023-08-10 |
| K213134 | Accu-Chek Solo micropump system with interoperable technology | Roche Diabetes Care GmbH | QFG | Class II | 2023-08-10 |
| K230625 | ReliOn Premier BLU Blood Glucose Monitoring System | I-Sens, Inc. | NBW | Class II | 2023-08-10 |
| K213131 | Accu-Chek Guide Solo diabetes manager blood glucose monitoring system | Roche Diabetes Care GmbH | NBW | Class II | 2023-08-10 |
| K223781 | Quantisal II Oral Fluid Collection Device | Immunalysis Corporation | PJD | Class II | 2023-07-28 |
| K223710 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | CGA | Class II | 2023-07-28 |
| K213536 | DEKA ACE Pump System | Deka Research and Development | QFG | Class II | 2023-07-25 |
| K222438 | A-LYTE® Integrated Multisensor (IMT Na K Cl) | Siemens Healthcare Diagnostics, Inc. | JGS | Class II | 2023-07-25 |
| K223637 | Elecsys proBNP II, Elecsys proBNP II STAT | Roche Diagnostics | NBC | Class II | 2023-07-21 |
| K223317 | Alkaline Phosphatase2 | Abbott Ireland Diagnostics Division | CJE | Class II | 2023-07-21 |
| K220977 | ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | JGS | Class II | 2023-07-20 |
| K210801 | AXINON® LDL-p Test System | Numares AG | MRR | Class I | 2023-07-19 |
| K213953 | BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes | Becton, Dickinson and Company | JKA | Class II | 2023-07-17 |
| K222116 | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) | Siemens Healthcare Diagnostics, Inc. | JLW | Class II | 2023-07-13 |
| K223213 | Tandem Mobi Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | QFG | Class II | 2023-07-10 |
| K230080 | Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood | Yangzhou Medline Industry, Co., Ltd. | JKA | Class II | 2023-07-07 |
| K223854 | Unistik® ShieldLock, Unistik VacuFlip | Owen Mumford, Ltd. | JKA | Class II | 2023-06-30 |
| DEN200052 | KidneyIntelX.dkd | Renalytix Ai, Inc. | QWZ | Class II | 2023-06-29 |
| K223722 | MIO Blood Glucose Monitoring System | Mio Labs, Inc. | NBW | Class II | 2023-06-28 |
| K231469 | PAXgene® Blood DNA Tube | Preanalytix GmbH | PJE | Class II | 2023-06-21 |
| K231485 | iLet® ACE Pump | Beta Bionics, Inc. | QFG | Class II | 2023-06-21 |
| K223078 | Atellica® CH Diazo Direct Bilirubin (D_DBil) | Siemens Healthcare Diagnostics, Inc. | CIG | Class II | 2023-06-12 |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | Abbott Laboratories | DHA | Class II | 2023-06-05 |
| K221801 | ADVIA Centaur® Anti-Müllerian Hormone (AMH) | Siemens Healthcare Diagnostics, Inc. | PQO | Class II | 2023-06-02 |
| K230408 | K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) | Sb-Kawasumi Laboratories, Inc. | JKA | Class II | 2023-06-01 |
| K223846 | iLet® ACE Pump | Beta Bionics, Inc. | QFG | Class II | 2023-05-19 |
| K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series | Abbott Laboratories | DHA | Class II | 2023-05-19 |
| K220916 | iLet® Dosing Decision Software | Beta Bionics, Inc. | QJI | Class II | 2023-05-19 |
| DEN220027 | B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System | Brahms GmbH, Part of Thermo Fisher Scientific | QWH | Class II | 2023-05-18 |
| K231081 | Dexcom G7 Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | QBJ | Class II | 2023-05-15 |
| K230994 | Alinity i STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | MMI | Class II | 2023-05-04 |
| K220677 | Kurin Blood Culture Collection Set with Kurin Lock Technology | Kurin, Inc. | JKA | Class II | 2023-04-28 |
| K223435 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. | QBJ | Class II | 2023-04-13 |
| K193514 | AUTION MAX AX-4060 Urinalysis System | Arkray, Inc. | JIL | Class II | 2023-04-13 |
| K220456 | Elecsys FT4 IV | Roche Diagnostics | CEC | Class II | 2023-04-07 |
| K220212 | BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder | Becton, Dickinson and Company | JKA | Class II | 2023-03-24 |
| K223323 | Blood Collection Needle (with/without Needle Holder) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | JKA | Class II | 2023-03-24 |
| K222104 | Atellica® CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics, Inc. | CIG | Class II | 2023-03-20 |
| K222478 | BD Vacutainer® Luer-Lok Access Device, BD Vacutainer® Blood Transfer Device | Becton, Dickinson and Company | JKA | Class II | 2023-03-10 |
| K222447 | FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. | QBJ | Class II | 2023-03-03 |
| K222280 | Bigfoot Unity® Diabetes Management System | Bigfoot Biomedical, Inc. | QLG | Class II | 2023-03-01 |
| K230038 | MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) | Guangzhou Decheng Biotechnology Co., Ltd. | LCX | Class II | 2023-02-28 |
| K223810 | Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) | Sb-Kawasumi Laboratories, Inc. | JKA | Class II | 2023-02-24 |
| K223537 | FreeStyle Libre 2 System, FreeStyle Libre 3 System | Abbott Diabetes Care, Inc. | QLG | Class II | 2023-02-21 |
| K223038 | Access Cortisol | Beckman Coulter, Inc. | CGR | Class II | 2023-02-08 |
| K223679 | Access AMH | Beckman Coulter, Inc. | PQO | Class II | 2023-02-03 |
| K211559 | EasyStat 300 | Medica Corporation | CHL | Class II | 2023-01-27 |
| K223090 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | CGA | Class II | 2023-01-27 |
| K203833 | Tacrolimus Assay Kit | Shanghai Genext Medical Technology Co., Ltd. | MLM | Class II | 2023-01-27 |
| K222779 | Revogene | Meridian Bioscience, Inc. | OOI | Class II | 2023-01-26 |
| K203689 | Tidepool Loop | Tidepool Project | QJI | Class II | 2023-01-23 |
| K223503 | Access 25(OH) Vitamin D Total | Beckman Coulter, Inc. | MRG | Class II | 2023-01-19 |
| K223405 | Access Testosterone | Beckman Coulter, Inc. | CDZ | Class I | 2023-01-13 |
| K223931 | Dexcom G6 Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | QBJ | Class II | 2023-01-11 |
| K223324 | Total Bilirubin2 | Abbott Ireland Diagnostics Division | CIG | Class II | 2022-12-29 |
| K221990 | Access Total ßhCG (5th IS) | Beckman Coulter, Inc. | DHA | Class II | 2022-12-27 |
| K223289 | Access Vitamin B12 | Beckman Coulter, Inc. | CDD | Class II | 2022-12-23 |
| K222234 | GlucoSure ADVANCE Link Blood Glucose Monitoring System | Apex BioTechnology Corp. | NBW | Class II | 2022-12-21 |
| K213919 | Dexcom G7 Continuous Glucose Monitoring System | Dexcom, Inc. | QBJ | Class II | 2022-12-07 |
| K222299 | Steripath Micro Blood Collection System | Magnolia Medical Technologies | JKA | Class II | 2022-11-30 |
| K222305 | MissLan Digital Pregnancy Rapid Test | Guangzhou Decheng Biotechnology Co., Ltd. | LCX | Class II | 2022-11-30 |
| K223293 | CONTOUR® NEXT GEN Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | NBW | Class II | 2022-11-18 |
| K221225 | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer | Beckman Coulter, Inc. | JLW | Class II | 2022-11-10 |
| K220421 | BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System | Apex BioTechnology Corp. | NBW | Class II | 2022-11-04 |
| K212745 | ORAcollect®Dx | DNA Genotek, Inc. | OYJ | Class II | 2022-10-27 |
| K213690 | Eclipse Blood Collection Set | Eclipse Medcorp, LLC | JKA | Class II | 2022-10-26 |
| K222141 | Safety Blood Collection Needle (Without Needle Holder) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | JKA | Class II | 2022-10-21 |
| K203549 | Nova Primary Glucose Analyzer System | Nova Biomedical Corporation | CGA | Class II | 2022-10-18 |
| K213061 | SuperCheck Pro Blood Glucose Monitoring System | Ok Biotech Co., Ltd. | NBW | Class II | 2022-10-07 |
| K201237 | Velano Vascular Blood Collection Adapter | Velano Vascular | JKA | Class II | 2022-10-03 |
| K213379 | Clearblue ® Early Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | LCX | Class II | 2022-09-21 |
| K220134 | cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH | Roche Diagnostics | CFR | Class II | 2022-09-16 |
| K213718 | SOL-GUARD Safety Pull Button Collection Set | Sol-Millennium Medical, Inc. | JKA | Class II | 2022-08-30 |
| K212248 | GlucoLeader Enhance 2 Blood Glucose Monitoring System | Hmd Biomedical, Inc. | NBW | Class II | 2022-08-29 |
| K220799 | K-SHIELD Zen | Sb-Kawasumi Laboratories, Inc. | JKA | Class II | 2022-08-29 |
| K212140 | GlucoSure Link Blood Glucose Monitoring System | Apex BioTechnology Corp. | NBW | Class II | 2022-08-25 |
| K222239 | SmartBolus Calculator | Insulet Corporation | QRX | Class II | 2022-08-19 |
13,065 clearances in the Clinical Chemistry panel. Data: openFDA.