Review Panel
Clinical Chemistry FDA 510(k) Clearances & Devices
- Cleared Devices
- 13,065
- Product Codes (page)
- 45
- Latest Decision
- 2022-08-19
Clearances · page 4 of 131
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K220394 | SmartAdjust(TM) technology | Insulet Corporation | QJI | Class II | 2022-08-19 |
| K202739 | Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System | Bioland Technology, Ltd. | NBW | Class II | 2022-08-12 |
| K220900 | Safety Blood Collection Needles with/without Needle Holder | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | JKA | Class II | 2022-08-10 |
| K221259 | Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | QBJ | Class II | 2022-07-29 |
| K220258 | 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) | Avia Vascular | JKA | Class II | 2022-07-14 |
| K220480 | Revogene | Meridian Bioscience, Inc. | OOI | Class II | 2022-07-11 |
| K210793 | VIDAS NEPHROCHECK | Biomérieux SA | PIG | Class II | 2022-07-08 |
| K210069 | Minuteful - kidney test | Healthy.Io, Ltd. | JIR | Class I | 2022-07-06 |
| K203597 | Cholesterol2 | Abbott Ireland Diagnostics Division | CHH | Class I | 2022-06-30 |
| K212418 | hCG One Step Pregnancy Test | Healstone Biotech, Inc. | LCX | Class II | 2022-06-30 |
| K201037 | FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System | Taidoc Technology Corporation | NBW | Class II | 2022-06-16 |
| K203757 | Elecsys AMH | Roche Diagnostics | PQO | Class II | 2022-06-10 |
| K203771 | Urea Nitrogen2 | Abbott Ireland Diagnostics Division | CDQ | Class II | 2022-05-31 |
| K213996 | FreeStyle Libre 3 Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. | QLG | Class II | 2022-05-26 |
| K210633 | Amylase2 | Abbott Ireland Diagnostics Division | JFJ | Class II | 2022-05-26 |
| K212132 | FreeStyle Libre 3 Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. | QLG | Class II | 2022-05-26 |
| K200788 | Assure Titanium Blood Glucose Monitoring System | Arkray, Inc. | PZI | Class II | 2022-05-23 |
| K202525 | Alinity i STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | MMI | Class II | 2022-05-19 |
| K203711 | IWL2020 Blood Glucose Monitoring System | Roche Diabetes Care, Inc. | NBW | Class II | 2022-05-06 |
| K211685 | Elecsys Testosterone II | Roche Diagnostics | CDZ | Class I | 2022-05-06 |
| K202534 | MTM301 Blood Glucose and Ketone Monitoring System | Apex BioTechnology Corp. | NBW | Class II | 2022-04-06 |
| K213808 | Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream | Co-Innovation Biotech Co., Ltd. | LCX | Class II | 2022-04-05 |
| K210546 | Elecsys proBNP II, Elecsys proBNP II STAT | Roche Diagnostics | NBC | Class II | 2022-03-31 |
| K213887 | GAL-1A Plus Blood Glucose Monitoring System | Apex BioTechnology Corp. | NBW | Class II | 2022-03-29 |
| K210452 | Creatinine2 | Abbott Ireland Diagnostics Division | CGX | Class II | 2022-03-22 |
| K203530 | Albumin BCP2 | Abbott Ireland Diagnostics Division | CJW | Class II | 2022-03-18 |
| K210341 | One Step Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | LCX | Class II | 2022-03-10 |
| K213486 | GLP systems Track | Abbott Laboratories | JGS | Class II | 2022-03-10 |
| K193406 | CardioChek Plus Test System; CardioChek Plus Home Test System | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | NBW | Class II | 2022-02-26 |
| K212447 | SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream | Hangzhou Sejoy Electronics & Instruments Co., Ltd. | LCX | Class II | 2022-02-18 |
| K203234 | t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) | Tandem Diabetes Care, Inc. | QFG | Class II | 2022-02-15 |
| K212724 | BD Vacutainer UltraTouch Push Button Blood Collection Set | Becton, Dickinson and Company | JKA | Class II | 2022-02-04 |
| K203272 | Alltest Pregnancy Rapid Combo Test Cassette | Hangzhou AllTest Biotech Co., Ltd. | JHI | Class II | 2022-01-31 |
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent Pack | Ortho Clinical Diagnostics | JHX | Class II | 2022-01-28 |
| K203768 | Omnipod 5 ACE Pump (Pod) | Insulet Corporation | QFG | Class II | 2022-01-27 |
| K203774 | SmartAdjust technology | Insulet Corporation | QJI | Class II | 2022-01-27 |
| K203772 | Omnipod 5 SmartBolus Calculator | Insulet Corporation | QRX | Class II | 2022-01-27 |
| DEN200059 | POMC/PCSK1/LEPR CDx Panel | Preventiongenetics, LLC | QRV | Class II | 2022-01-21 |
| K193407 | Contour® next GEN Blood Glucose Monitoring System | Ascensia Diabetes Care | NBW | Class II | 2021-12-23 |
| K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer | Diazyme Laboratories, Inc. | DHA | Class II | 2021-12-13 |
| K212223 | Atellica CH Enzymatic Creatinine_3 (ECre3) | Siemens Healthcare Diagnostics, Inc. | JFY | Class II | 2021-11-24 |
| K203248 | Albumin BCG2 | Abbott Ireland Diagnostics Division | CIX | Class II | 2021-11-23 |
| K210943 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | Abbott Diabetes Care, Inc. | QLG | Class II | 2021-11-22 |
| K211199 | ST AIA-PACK BNP Assay | Tosoh Bioscience, Inc. | NBC | Class II | 2021-11-08 |
| K212019 | Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single | Jiangsu Micsafe Medical Technology Co., Ltd. | JKA | Class II | 2021-11-04 |
| K200865 | Piccolo Potassium Test System | Abaxis, Inc. | MZV | Class II | 2021-10-20 |
| K201880 | MultiSure GK Link Blood Glucose and Ketone Monitoring System | Apex BioTechnology Corp. | NBW | Class II | 2021-10-15 |
| K201394 | CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System | I-Sens, Inc. | NBW | Class II | 2021-10-05 |
| K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack | Ortho Clinical Diagnostics | NBC | Class II | 2021-10-04 |
| K210561 | Advisor Pro Platform | DreaMed Diabetes, Ltd. | QCC | Class II | 2021-09-28 |
| K201441 | Elecsys Troponin T Gen 5 | Roche Diagnostics | MMI | Class II | 2021-09-21 |
| K200898 | Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin | Medicon Hellas S.A | CIX | Class II | 2021-09-21 |
| K202885 | GlucoSure HT Plus Blood Glucose Monitoring System | Apex BioTechnology Corp. | NBW | Class II | 2021-09-15 |
| K210901 | Elecsys Vitamin D total III | Roche Diagnostics | MRG | Class II | 2021-09-01 |
| K201258 | EASYMAX Tag Self-Monitoring Blood Glucose System | Eps Bio Technology Corp. | NBW | Class II | 2021-09-01 |
| K203790 | GEM Premier 5000 | Instrumentation Laboratory CO | CHL | Class II | 2021-08-20 |
| DEN190056 | ADVIA Centaur Enhanced Liver Fibrosis (ELF) | Siemens Healthcare Diagnostics, Inc. | QQB | Class II | 2021-08-20 |
| K203227 | Elecsys HCG STAT | Roche Diagnostics | DHA | Class II | 2021-08-18 |
| K203089 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | QDK | Class II | 2021-08-17 |
| K200913 | Clearblue® Early Digital Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | LCX | Class II | 2021-08-13 |
| K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | CGA | Class II | 2021-08-13 |
| K211102 | FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. | QLG | Class II | 2021-08-11 |
| K210687 | CONTOUR® NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | NBW | Class II | 2021-08-11 |
| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 | Tosoh Bioscience, Inc. | PDJ | Class II | 2021-08-05 |
| K203246 | Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream) | Atlas Link Technology Co., Ltd. | LCX | Class II | 2021-08-04 |
| K200986 | OPTI® B-Lac Cassette | Opti Medical Systems, Inc. | CHL | Class II | 2021-08-02 |
| K201761 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | Abbott Diabetes Care, Inc. | QLG | Class II | 2021-07-30 |
| K201009 | CHIRAVAC Blood Collection Needles | Chirana T. Injecta | JKA | Class II | 2021-07-21 |
| K201328 | Dexcom G6 Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | QBJ | Class II | 2021-07-15 |
| K200210 | ADVIA Centaur® Total hCG assay | Siemens Healthcare Diagnostics, Inc. | DHA | Class II | 2021-07-13 |
| K203562 | Finetest Lite Blood Glucose Monitoring System | Osang Healthcare Co. , Ltd. | NBW | Class II | 2021-07-13 |
| K200256 | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay | Siemens Healthcare Diagnostics, Inc. | PDJ | Class II | 2021-07-02 |
| K193649 | Yumizen C1200 Creatinine PAP | HORIBA ABX SAS | JFY | Class II | 2021-05-10 |
| K202145 | Bigfoot Unity Diabetes Management System | Bigfoot Biomedical, Inc. | QLG | Class II | 2021-05-07 |
| K202136 | IDS Cortisol | Immunodiagnostic Systems , Ltd. | CGR | Class II | 2021-04-13 |
| K202325 | EasyPoint Blood Collection Plus | Retractable Technologies, Inc. | JKA | Class II | 2021-04-09 |
| K202188 | Safety Blood Collection Sets for Single Use | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | JKA | Class II | 2021-02-19 |
| K203270 | IMMULITE/IMMULITE® 1000 Cortisol | Siemens Healthcare Diagnostics Products, Ltd. | CGR | Class II | 2021-01-15 |
| K202826 | IMMULITE® 2000 Cortisol | Siemens Healthcare Diagnostics Products, Ltd. | CGR | Class II | 2021-01-15 |
| K200876 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System | Dexcom, Inc. | QBJ | Class II | 2020-12-04 |
| K201396 | Finetest Lite Smart Blood Glucose Monitoring System | Osang Healthcare Co. , Ltd. | NBW | Class II | 2020-10-16 |
| K201908 | LIAISON Testosterone xt | DiaSorin, Inc. | CDZ | Class I | 2020-10-15 |
| K200544 | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ | Diamond Diagnostics, Inc. | CEM | Class II | 2020-10-01 |
| K200475 | IDS-iSYS Ostase BAP | Immunodiagnostic Systems , Ltd. | CIN | Class II | 2020-09-30 |
| K202446 | BD Preset Syringe & BD A-Line Syringe | Becton, Dickinson and Company | JKA | Class II | 2020-09-25 |
| K193340 | GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System | Microtech Medical, Inc. | NBW | Class II | 2020-09-11 |
| K192730 | CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV | Biosystems S.A. | CHW | Class II | 2020-09-09 |
| K201551 | KetoSens BT Blood B-Ketone Monitoring System | I-Sens, Inc. | JIN | Class I | 2020-09-09 |
| K200027 | Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter | Jiangsu Caina Medical Co.,Ltd | JKA | Class II | 2020-09-09 |
| K201476 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | QCC | Class II | 2020-08-28 |
| K192380 | ST AIA-PACK BNP | Fujirebio Diagnostics,Inc. | NBC | Class II | 2020-08-24 |
| K193318 | Distinct® Early Detection Pregnancy Test | ACON Laboratories, Inc. | LCX | Class II | 2020-08-20 |
| K200133 | hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream | Safecare Biotech (Hangzhou) Co., Ltd. | LCX | Class II | 2020-08-13 |
| K192947 | AncestryDNA Saliva Collection Kit | Ancestry Genomics, Inc. | OYJ | Class II | 2020-08-13 |
| K191296 | Pointe Scientific Creatinine Kinase (CK) Reagent Set | Medtest DX | CGS | Class II | 2020-08-11 |
| DEN200001 | Cell-Free DNA BCT | Streck, Inc. | QMA | Class II | 2020-08-07 |
| K200801 | Quantisal Oral Fluid Collection Device | Immunalysis Corporation | PJD | Class II | 2020-07-28 |
| K200467 | Control-IQ Technology | Tandem Diabetes Care, Inc. | QJI | Class II | 2020-06-16 |
| K193371 | FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. | QLG | Class II | 2020-06-12 |
| K200107 | epoc Blood Analysis System | Epocal, Inc. | CHL | Class II | 2020-06-05 |
13,065 clearances in the Clinical Chemistry panel. Data: openFDA.