Review Panel
Clinical Chemistry FDA 510(k) Clearances & Devices
- Cleared Devices
- 13,065
- Product Codes (page)
- 51
- Latest Decision
- 2020-06-05
Clearances · page 5 of 131
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K192957 | VivaChek Blood Glucose and B-Ketone Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | JIN | Class I | 2020-06-05 |
| K201214 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | QFG | Class II | 2020-06-04 |
| K200277 | Livongo Blood Glucose Monitoring System (BG1000) | Livongo Health, Inc. | NBW | Class II | 2020-06-04 |
| K200509 | ADVIA Centaur Vitamin D Total (VitD) | Siemens Healthcare Diagnostics, Inc. | MRG | Class II | 2020-05-29 |
| K192586 | LIAISON® Folate | DiaSorin, Inc. | CGN | Class II | 2020-05-06 |
| K193074 | Bevel Up Holder | Nsp Tech Pte, Ltd. | JKA | Class II | 2020-04-21 |
| DEN190028 | MyCare Psychiatry Clozapine Assay Kit | Saladax Biomedical, Inc. | QKT | Class II | 2020-04-16 |
| K200403 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | JGS | Class II | 2020-04-14 |
| K200492 | i-STAT CG4+ Cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | CHL | Class II | 2020-04-09 |
| K192240 | RAPIDPoint 500e Blood Gas System | Siemens Healthcare Diagnostics, Inc. | CHL | Class II | 2020-03-27 |
| K193053 | Tina-quant Hemoglobin A1cDx Gen.3 | Roche Diagnostics Operations (Rdo) | PDJ | Class II | 2020-03-26 |
| K191657 | Bioland Blood Glucose Monitoring System | Bioland Technology, Ltd. | NBW | Class II | 2020-03-20 |
| K200349 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | CGA | Class II | 2020-03-13 |
| K192247 | Steripath Gen2 Blood Collection System | Magnolia Medical Technologies, Inc. | JKA | Class II | 2020-02-28 |
| K193483 | Basal-IQ Technology | Tandem Diabetes Care, Inc. | QJS | Class II | 2020-02-28 |
| K191462 | Proov Test | Mfb Fertility, Inc. | QKE | Class I | 2020-02-27 |
| K191030 | Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer | Life Technologies Corporation | PCA | Class II | 2020-02-21 |
| K193475 | OneTouch Verio Reflect Blood Glucose Monitoring System | Lifescan Europe GmbH | NBW | Class II | 2020-02-14 |
| K191360 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | JFP | Class II | 2020-02-14 |
| K183678 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | CGA | Class II | 2020-02-07 |
| K191298 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | JFL | Class II | 2020-02-07 |
| K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | JGS | Class II | 2020-02-07 |
| K193103 | NeoBase 2 Non-derivatized MSMS Kit | Perkinelmer, Inc. | NQL | Class II | 2020-02-07 |
| K191832 | Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223) | Kurin, Inc. | JKA | Class II | 2020-02-04 |
| K193642 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | QDK | Class II | 2020-01-29 |
| K192859 | CareSens S Clear BT Blood Glucose Monitoring System | I-Sens, Inc. | NBW | Class II | 2020-01-24 |
| K193246 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | CHL | Class II | 2020-01-24 |
| K193569 | PIVO(TM) | Velano Vascular | JKA | Class II | 2020-01-21 |
| K192547 | MAGLUMI 2000 HCG/ß-HCG | Shenzhen New Industries Biomedical Engineering Co., Ltd. | DHA | Class II | 2020-01-17 |
| K193590 | CareSens S Fit BT Blood Glucose Monitoring System | I-Sens, Inc. | NBW | Class II | 2020-01-17 |
| K192920 | Oragene®Dx | DNA Genotek, Inc. | OYJ | Class II | 2020-01-14 |
| K191350 | ACTIVE® Free Testosterone RIA | Immunotech S.R.O. | CDZ | Class I | 2019-12-20 |
| K193001 | Albumin BCP | SENTINEL CH. SpA | CJW | Class II | 2019-12-19 |
| DEN190034 | Control-IQ Technology | Tandem Diabetes Care, Inc. | QJI | Class II | 2019-12-13 |
| K192220 | ReliOn Premier Classic Blood Glucose Monitoring System | I-Sens, Inc. | NBW | Class II | 2019-12-13 |
| DEN180056 | GSP Neonatal Creatine Kinase - MM kit | Perkinelmer, Inc. | QJE | Class II | 2019-12-12 |
| K193132 | CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream | Hangzhou Clongene Biotech Co., Ltd. | LCX | Class II | 2019-12-11 |
| K192788 | ADVIA Centaur Cortisol (COR) | Siemens Healthcare Diagnostics, Inc. | JFT | Class II | 2019-11-25 |
| K192843 | INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream | Innovita (Tangshan) Biological Technology Co., Ltd. | LCX | Class II | 2019-11-22 |
| K191286 | CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System | Ascensia Diabetes Care | NBW | Class II | 2019-11-08 |
| K190335 | GSP Neonatal Total Galactose kit | Perkinelmer, Inc. | JIA | Class I | 2019-11-06 |
| K190225 | TAP Blood Collection Device | Seventh Sense Biosystems, Inc. | PRJ | Class II | 2019-11-05 |
| K190189 | MDT2 BLE Self-Monitoring Blood Glucose System | Eps Bio Technology Corp. | NBW | Class II | 2019-11-01 |
| K192790 | Atellica IM Total hCG (ThCG) | Siemens Healthcare Diagnostics, Inc. | DHA | Class II | 2019-10-30 |
| K192787 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System | Dexcom, Inc. | QDK | Class II | 2019-10-25 |
| K192175 | On Call Express II Blood Glucose Monitoring System | ACON Laboratories, Inc. | NBW | Class II | 2019-10-17 |
| K191833 | Dexcom G6 Pro Continuous Glucose Monitoring System | Dexcom, Inc. | QII | Class II | 2019-10-07 |
| K190298 | DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 | Beckman Coulter Biomedical GmbH | CDD | Class II | 2019-10-04 |
| K192064 | LIAISON Vitamin B12 | DiaSorin, Inc. | CDD | Class II | 2019-10-02 |
| K191679 | Omnipod DASH Insulin Management System with interoperable technology | Insulet Corporation | QFG | Class II | 2019-09-20 |
| K191595 | ARCHITECT STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | MMI | Class II | 2019-09-13 |
| K192123 | HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream | Qingdao Hightop Biotech Co., Ltd. | LCX | Class II | 2019-09-05 |
| K191245 | Yumizen C1200 ALP, Yumizen C1200 Albumin | HORIBA ABX SAS | CJE | Class II | 2019-08-30 |
| K190702 | Lumipulse G whole PTH | Fujirebio Diagnostics,Inc. | CEW | Class II | 2019-08-30 |
| K191533 | ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG | Siemens Healthcare Diagnostics, Inc. | CDZ | Class I | 2019-08-28 |
| K191626 | Stat Profile Prime ES Comp Plus Analyzer System | Nova Biomedical Corporation | JFP | Class II | 2019-08-16 |
| K191899 | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions | Roche Diagnostics | CFR | Class II | 2019-08-16 |
| K191499 | MAGLUMI 2000 25-OH Vitamin D | Shenzhen New Industries Biomedical Engineering Co., Ltd. | MRG | Class II | 2019-08-01 |
| K191454 | Atellica CH Amylase_2 (AMY_2) | Siemens Healthcare Diagnostics, Inc. | JFJ | Class II | 2019-07-30 |
| K181743 | Blood Transfer Accessory (BTA) | Nsp Tech Pte, Ltd. | JKA | Class II | 2019-07-30 |
| K181754 | Blood Collection Accessory (BUCA) | Nsp Tech Pte, Ltd. | JKA | Class II | 2019-07-30 |
| K183048 | Quantisal II Oral Fluid Collection Device | Immunalysis Corporation | PJD | Class II | 2019-07-29 |
| K182384 | ACR LAB Urine Analysis Test System | Healthy.Io, Ltd. | JFY | Class II | 2019-07-26 |
| K191396 | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe | HORIBA ABX SAS | CJY | Class II | 2019-07-26 |
| K191365 | Stat Profile Prime ES Comp Plus Analyzer System | Nova Biomedical Corporation | JGS | Class II | 2019-07-19 |
| K191370 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | QCC | Class II | 2019-07-18 |
| K190485 | Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) | Kawasumi Laboratories, Inc. | JKA | Class II | 2019-07-08 |
| K191450 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System | Dexcom, Inc. | QBJ | Class II | 2019-06-28 |
| K190121 | IDS SHBG | Immunodiagnostic Systems , Ltd. | CDZ | Class I | 2019-06-17 |
| K191038 | On Call Express Voice Blood Glucose Monitoring System | ACON Laboratories, Inc. | NBW | Class II | 2019-06-12 |
| K172232 | LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 | Ams Diagnostics | JGS | Class II | 2019-06-12 |
| K191316 | VITROS XT Chemistry Products ALB-TP Slides | Ortho-Clinical Diagnostics, Inc. | CIX | Class II | 2019-06-07 |
| K190579 | TD-4183 Blood Glucose Monitoring System | Taidoc Technology Corporation | NBW | Class II | 2019-06-04 |
| K190564 | Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB | Bionime Corporation | NBW | Class II | 2019-06-02 |
| K183205 | PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System | Emcyte Corporation | JQC | Class I | 2019-05-30 |
| K190675 | Dimension EXL High-Sensitivity Troponin I (TNIH) Assay | Siemens Healthcare Diagnostics, Inc. | MMI | Class II | 2019-05-17 |
| K182328 | VeriClear Digital Early Result Pregnancy Test | True Diagnostics, Inc. | LCX | Class II | 2019-05-15 |
| K190604 | PIVO | Velano Vascular | JKA | Class II | 2019-05-13 |
| K182428 | GlucoLeader Enhance Blood Glucose Monitoring System | Hmd Biomedical, Inc. | NBW | Class II | 2019-05-08 |
| K183432 | cobas u 601 urinalysis test system | Roche Diagnostics | JIL | Class II | 2019-05-07 |
| K190266 | NeoLSD MSMS Kit | Perkinelmer, Inc. | PQW | Class II | 2019-05-03 |
| K182474 | alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL | Biosystems S.A. | JFJ | Class II | 2019-05-02 |
| K190807 | VITROS XT Chemistry Products TBIL-ALKP Slides | Ortho-Clinical Diagnostics, Inc. | CIG | Class II | 2019-04-26 |
| K182702 | SEKURE Creatine Kinase Assay | Sekisui Diagnostics P.E.I., Inc. | CGS | Class II | 2019-04-17 |
| K190773 | Elecsys TSH | Roche Diagnostics | JLW | Class II | 2019-04-16 |
| K190705 | WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream | Wholepower Biotech Co., Ltd. | LCX | Class II | 2019-04-15 |
| K183306 | GLUCOCARD® W onyx Blood Glucose Monitoring System | Arkray Factory, Inc. | NBW | Class II | 2019-04-10 |
| K190520 | VITROS XT Chemistry Products GLU-Ca Slides | Ortho-Clinical Diagnostics, Inc. | CGA | Class II | 2019-04-03 |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL Slides | Ortho-Clinical Diagnostics, Inc. | CHH | Class I | 2019-03-27 |
| K190326 | VITROS XT Chemistry Products UREA-CREA Slides | Ortho-Clinical Diagnostics, Inc. | CDN | Class II | 2019-03-14 |
| K182225 | Dimension Vista High-Sensitivity Troponin I (TNIH) Assay | Siemens Healthcare Diagnostics, Inc. | MMI | Class II | 2019-03-04 |
| K181551 | DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette | Runbio Biotech Co.,Ltd | LCX | Class II | 2019-02-22 |
| K183549 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | JGS | Class II | 2019-02-16 |
| K183546 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | CGA | Class II | 2019-02-16 |
| K183555 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | JFY | Class II | 2019-02-16 |
| K183206 | Dexcom G6 Continuous Glucose Monitoring System | Dexcom, Inc. | QBJ | Class II | 2019-02-14 |
| DEN180058 | t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | QFG | Class II | 2019-02-14 |
| K183375 | Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode | Horiba, Ltd. | JJE | Class I | 2019-02-12 |
| K183517 | Ammonia II | Roche Diagnostics Operations (Rdo) | JIF | Class I | 2019-02-08 |
| K181070 | iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) | Andon Health Co, Ltd. | NBW | Class II | 2019-02-01 |
13,065 clearances in the Clinical Chemistry panel. Data: openFDA.