Review Panel
Clinical Chemistry FDA 510(k) Clearances & Devices
- Cleared Devices
- 13,065
- Product Codes (page)
- 41
- Latest Decision
- 2025-02-07
Clearances · page 2 of 131
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K241453 | Elecsys sFlt-1 and Elecsys PlGF | Roche Diagnostics | QWH | Class II | 2025-02-07 |
| K242135 | Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream | Nanjing Synthgene Medical Technology Co., Ltd. | LCX | Class II | 2025-01-31 |
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring System | Guangdong Transtek Medical Electronics Co., Ltd. | NBW | Class II | 2025-01-30 |
| K241176 | Alere NT-proBNP for Alinity i Reagent Kit | Axis-Shield Diagnostics, Ltd. | NBC | Class II | 2025-01-16 |
| K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream | Assure Tech., LLC | LCX | Class II | 2025-01-15 |
| K241037 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | CEM | Class II | 2025-01-14 |
| K242767 | Safecare Urinary Tract Infection Test | Safecare Biotech (Hangzhou) Co., Ltd. | JMT | Class I | 2025-01-10 |
| K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | MMI | Class II | 2025-01-03 |
| K241394 | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip | Andon Health Co, Ltd. | LCX | Class II | 2024-12-20 |
| K240998 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | CHL | Class II | 2024-12-13 |
| K242685 | Atellica® CH Creatinine_3 (Crea3) | Siemens Healthcare Diagnostics, Inc. | CGX | Class II | 2024-12-04 |
| K221813 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | CGX | Class II | 2024-11-19 |
| K221349 | XPER Technology PREMIUM Pro Blood Glucose Monitoring System | Taidoc Technology Corporation | PZI | Class II | 2024-11-19 |
| K240637 | RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation | NBW | Class II | 2024-11-04 |
| K242320 | BD Vacutainer® One Use Holder | Becton, Dickinson and Company | JKA | Class II | 2024-11-01 |
| K240455 | BD Vacutainer® Citrate Blood Collection Tubes | Becton, Dickinson and Company | GIM | Class II | 2024-10-31 |
| K240865 | IDS-iSYS Free Testosterone | Immunodiagnostic Systems Limited | CDZ | Class I | 2024-10-23 |
| K240468 | Alkaline Phosphatase | Abbott Laboratories Diagnostics Division | CJE | Class II | 2024-10-16 |
| K240242 | HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold) | Anhui Deepblue Medical Technology Co., Ltd. | LCX | Class II | 2024-10-11 |
| K240640 | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System | Sejoy Biomedical Co., Ltd. | NBW | Class II | 2024-10-08 |
| K210933 | YSI 2900C Biochemistry Analyzer | Ysi, Inc. | CGA | Class II | 2024-09-30 |
| K241335 | Eversense 365 Continuous Glucose Monitoring (CGM) System | Senseonics, Incorporated | SBA | Class II | 2024-09-16 |
| K220999 | Hipro Glycosylated Hemoglobin (HbA1c) Test System | Shijiazhuang Hipro Biotechnology Co., Ltd. | PDJ | Class II | 2024-09-12 |
| K234027 | embecta Insulin Delivery System | Embecta Medical I, LLC | QFG | Class II | 2024-08-30 |
| K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | NBW | Class II | 2024-08-27 |
| K241777 | SmartAdjust Technology | Insulet Corporation | QJI | Class II | 2024-08-26 |
| K222126 | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | NBW | Class II | 2024-08-16 |
| K241978 | Shinetell Digital Pregnancy Test | Hangzhou AllTest Biotech Co., Ltd. | LCX | Class II | 2024-08-13 |
| K232404 | CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES | Medicon Hellas S.A | CHH | Class I | 2024-08-09 |
| K241919 | Innovita HCG Pregnancy Rapid Combo Test | Innovita (Tangshan) Biological Technology Co., Ltd. | JHI | Class II | 2024-08-02 |
| K233541 | ARCHITECT Active-B12 (Holotranscobalamin) | Axis-Shield Diagnostics, Ltd. | CDD | Class II | 2024-07-31 |
| K231776 | Cell-Free DNA BCT | Streck, Inc. | QMA | Class II | 2024-07-26 |
| K241800 | Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) | Siemens Healthcare Diagnostics, Inc. | MRR | Class I | 2024-07-26 |
| K220328 | EasyStat 300 | Medica Corporation | CGA | Class II | 2024-07-26 |
| K241078 | Tandem Mobi Insulin Pump with interoperable technology | Tandem Diabetes Care, Inc. | QFG | Class II | 2024-07-26 |
| K241165 | Atellica® IM High-Sensitivity Troponin I (TnIH) | Siemens Healthcare Diagnostics, Inc. | MMI | Class II | 2024-07-25 |
| K234091 | Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 | Genalyte, Inc. | JLW | Class II | 2024-07-22 |
| K233979 | VACUETTE® QUICKSHIELD Complete (Plus) | Greiner Bio-One North America, Inc. | JKA | Class II | 2024-07-19 |
| K240643 | MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream | Guangzhou Decheng Biotechnology Co., Ltd. | LCX | Class II | 2024-06-21 |
| K233060 | Elecsys Folate III | Roche Diagnostics | CGN | Class II | 2024-06-17 |
| K233861 | Libre Rio Continuous Glucose Monitoring System | Abbott Diabetes Care | SBH | Class II | 2024-06-07 |
| K241304 | WaveSense Jazz Blood Glucose Monitoring System | Agamatrix | NBW | Class II | 2024-06-06 |
| K232715 | Distinct® Digital Pregnancy Test | ACON Laboratories, Inc. | LCX | Class II | 2024-05-31 |
| K233655 | Lingo Glucose System | Abbott | SAF | Class II | 2024-05-29 |
| K232741 | SmartAdjust(TM) technology | Insulet Corporation | QJI | Class II | 2024-05-29 |
| K241178 | DEKA ACE Pump System | Deka Research and Development | QFG | Class II | 2024-05-24 |
| K232603 | CamAPS FX | Camdiab , Ltd. | QJI | Class II | 2024-05-23 |
| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack | Ortho Clinical Diagnostics | DHA | Class II | 2024-05-08 |
| K234088 | Emily's Care Nourish Test System (Model 1) | Lactation Lab, Inc. | QEI | Class II | 2024-05-03 |
| K240800 | Access Intrinsic Factor Ab | Beckman Coulter, Inc. | LIG | Class II | 2024-05-03 |
| DEN230052 | Eversense AP CGM System | Senseonics, Incorporated | SBA | Class II | 2024-04-29 |
| K220272 | cobas pulse blood glucose monitoring system | Roche Diagnostics | PZI | Class II | 2024-04-26 |
| K240902 | Dexcom G7 Continuous Glucose Monitoring System | Dexcom, Inc. | QBJ | Class II | 2024-04-23 |
| K233537 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. | QBJ | Class II | 2024-04-23 |
| K232904 | Access Ostase | Beckman Coulter | CIN | Class II | 2024-04-15 |
| K232587 | MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer | Shenzhen New Industries Biomedical Engineering Co., Ltd. | MRG | Class II | 2024-04-12 |
| K232164 | Access NT-proBNP | Beckman Coulter, Inc. | NBC | Class II | 2024-04-12 |
| K233624 | HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx | Hangzhou Aichek Medical Technology Co., Ltd. | LCX | Class II | 2024-04-12 |
| K234152 | ACESO Early Pregnancy Test | Aceso Laboratories, Inc. | LCX | Class II | 2024-04-05 |
| K233050 | ADVIA Centaur® TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | JLW | Class II | 2024-04-04 |
| K231927 | Elecsys PTH , Elecsys PTH STAT | Roche Diagnostics | CEW | Class II | 2024-03-22 |
| K240309 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | QFG | Class II | 2024-03-21 |
| K231974 | PATHFAST®hs-cTnI-II | Phc Corporation | MMI | Class II | 2024-03-20 |
| K233952 | DEKA ACE Pump System | Deka Research and Development | QFG | Class II | 2024-03-13 |
| K234055 | DEKA Loop | Deka Research and Development | QJI | Class II | 2024-03-13 |
| K232781 | Safety Sliding Blood Collection Set | Jiangsu Caina Medical Co.,Ltd | JKA | Class II | 2024-03-07 |
| K240273 | Access Free T4 | Beckman Coulter, Inc. | CEC | Class II | 2024-03-06 |
| K234070 | Stelo Glucose Biosensor System | Dexcom, Inc. | SAF | Class II | 2024-03-05 |
| K232791 | Access Intact PTH | Beckman Coulter, Inc. | CEW | Class II | 2024-03-01 |
| K234133 | Dexcom G7 Continuous Glucose Monitoring System | Dexcom, Inc. | QBJ | Class II | 2024-02-26 |
| K231679 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System | Ascensia Diabetes Care | NBW | Class II | 2024-02-23 |
| K232075 | StatStrip Glucose Hospital Meter System | Nova Biomedical Corporation | PZI | Class II | 2024-02-23 |
| K234005 | Access CK-MB | Beckman Coulter, Inc. | JHX | Class II | 2024-02-16 |
| K233480 | Access SHBG | Beckman Coulter, Inc. | CDZ | Class I | 2024-02-08 |
| K233174 | FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream | Assure Tech. (Hangzhou) Co, Ltd. | LCX | Class II | 2024-02-05 |
| K231373 | BD Vacutainer® K2 EDTA Blood Collection Tubes | Becton, Dickinson and Company | JKA | Class II | 2024-02-02 |
| K240025 | Clearblue® Early Detection Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | LCX | Class II | 2024-01-31 |
| K232864 | EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II | Nantong Egens Biotechnology Co., Ltd. | LCX | Class II | 2024-01-26 |
| K231282 | LifeOutcomes C-Quest Blood Culture Sampling Device | Lifeoutcomes, LLC | JKA | Class II | 2024-01-26 |
| K231237 | BD Vacutainer® Fluoride Blood Collection Tubes | Becton, Dickinson and Company | JKA | Class II | 2024-01-19 |
| K231192 | RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation | NBW | Class II | 2024-01-19 |
| K233058 | VivaChek Link Plus Blood Glucose Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | NBW | Class II | 2023-12-22 |
| K232881 | Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder | Jiangsu Kangbao Medical Equipment Co., Ltd. | JKA | Class II | 2023-12-22 |
| K230545 | Inessa System | Triple Jump Israel , Ltd. | QFG | Class II | 2023-12-20 |
| K230855 | BD Vacutainer® Serum Separator (SST) Blood Collection Tubes | Becton, Dickinson and Company | JKA | Class II | 2023-12-20 |
| K222881 | Access hsTnI | Beckman Coulter, Inc. | MMI | Class II | 2023-12-18 |
| K223690 | iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) | Shenzhen Yhlo Biotech Co., Ltd. | DHA | Class II | 2023-12-11 |
| K232761 | ProNephro AKI (NGAL) | Bioporto Diagnostic, Inc. | PIG | Class II | 2023-12-07 |
| K230648 | Access hsTnI | Beckman Coulter, Inc. | MMI | Class II | 2023-12-04 |
| K232308 | Monarch Blood Collection Set | The Monarch Company | JKA | Class II | 2023-12-04 |
| K231476 | TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System | Sinocare, Inc. | NBW | Class II | 2023-12-01 |
| K230391 | BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube | Becton, Dickinson and Company | JKA | Class II | 2023-12-01 |
| K230493 | BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube | Becton, Dickinson and Company | GIM | Class II | 2023-11-27 |
| K232898 | Quantisal Oral Fluid Collection Device | Immunalysis Corporation | PJD | Class II | 2023-11-21 |
| K232382 | Control-IQ Technology | Tandem Diabetes Care, Inc. | QJI | Class II | 2023-11-03 |
| K232380 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | QFG | Class II | 2023-11-03 |
| K213146 | Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen | Jiangsu Rongye Technology Co., Ltd. | JKA | Class II | 2023-10-27 |
| K230300 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | JFP | Class II | 2023-10-27 |
| K230285 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | CHL | Class II | 2023-10-27 |
| K230275 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | JGS | Class II | 2023-10-27 |
13,065 clearances in the Clinical Chemistry panel. Data: openFDA.