Review Panel
Clinical Chemistry FDA 510(k) Clearances & Devices
- Cleared Devices
- 13,065
- Product Codes (page)
- 41
- Latest Decision
- 2019-01-29
Clearances · page 6 of 131
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K182521 | FastPack IP Sex Hormone Binding Globulin Immunoassay | Qualigen, Inc. | CDZ | Class I | 2019-01-29 |
| K182078 | MiniCollect K2E K2EDTA Tubes | Greiner Bio-One Na, Inc. | JKA | Class II | 2019-01-25 |
| K181895 | Kurin PIV Blood Collection Set with High Pressure | Kurin, Inc. | JKA | Class II | 2019-01-18 |
| K182651 | HbA1c Advanced | Beckman Coulter Ireland, Inc. | PDJ | Class II | 2019-01-16 |
| K183097 | Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream | Weihai Kangzhou Biotechnology Engineering Co., Ltd. | LCX | Class II | 2019-01-10 |
| K182781 | PTS Professional Chemistry Kit | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | CGA | Class II | 2018-12-21 |
| DEN180007 | Miris Human Milk Analyzer | Miris AB | QEI | Class II | 2018-12-21 |
| K182012 | ADVIA Centaur Calcitonin (CALCT) assay | Axis-Shield Diagnostics Limited | JKR | Class II | 2018-12-21 |
| K173140 | VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System | Vivachek Laboratories, Inc. | NBW | Class II | 2018-12-19 |
| K182593 | KET-1 Blood Ketone Monitoring System | Apex BioTechnology Corp. | JIN | Class I | 2018-12-18 |
| K182552 | StatStrip Xpress Glucose Hospital Meter System | Nova Biomedical Corporation | PZI | Class II | 2018-12-13 |
| K182549 | StatStrip Xpress 2 Glucose Hospital Meter System | Nova Biomedical Corporation | PZI | Class II | 2018-12-13 |
| K181131 | Accu-Chek Guide Me Blood Glucose Monitoring System | Roche Diabetes Care | NBW | Class II | 2018-12-13 |
| K181675 | FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System | Taidoc Technology Corporation | PTC | Class I | 2018-12-10 |
| K182038 | URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer | Yd Diagnostics Corporation | JFY | Class II | 2018-12-10 |
| K182046 | Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System | Tyson Bioresearch, Inc. | NBW | Class II | 2018-11-30 |
| K181588 | POPS! one Blood Glucose Monitoring System | Taidoc Technology Corporation | NBW | Class II | 2018-11-30 |
| K182047 | Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System | Tyson Bioresearch, Inc. | NBW | Class II | 2018-11-29 |
| K182988 | Afinion HbA1c Dx on Afinion 2 | Alere Technologies AS | PDJ | Class II | 2018-11-29 |
| K182992 | BGM014 Blood Glucose Monitoring System | Apex BioTechnology Corp. | NBW | Class II | 2018-11-28 |
| K173857 | Elecsys Tacrolimus | Roche Diagnostics | MLM | Class II | 2018-11-06 |
| K182405 | Dexcom Pro Q Continuous Glucose Monitoring System | Dexcom, Inc. | QDL | Class II | 2018-11-02 |
| K181273 | GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System | I-Sens, Inc. | NBW | Class II | 2018-11-01 |
| K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System | Ortho-Clinical Diagnostics, Inc. | JFY | Class II | 2018-10-30 |
| K182072 | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides | Ortho-Clinical Diagnostics, Inc. | CGZ | Class II | 2018-10-30 |
| K182041 | Dexcom G6 Glucose Program Continuous Glucose Monitoring System | Dexcom, Inc. | QDK | Class II | 2018-10-26 |
| DEN180004 | picoAMH ELISA | Ansh Labs, LLC | QDH | Class II | 2018-10-24 |
| K182042 | Randox Calcium (Ca) | Randox Laboratories, Ltd. | CJY | Class II | 2018-10-23 |
| K181373 | Extended Lipid Panel Assay | Laboratory Corporation of America Holdings | CHH | Class I | 2018-10-18 |
| K182423 | MAGLUMI 2000 FT4 | Shenzhen New Industries Biomedical Engineering Co., Ltd. | CEC | Class II | 2018-10-04 |
| K181527 | On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System | ACON Laboratories, Inc. | NBW | Class II | 2018-10-03 |
| K180340 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | CGA | Class II | 2018-09-26 |
| K182286 | Oh'Care Lite Smart Blood Glucose Monitoring System | Osang Healthcare Co. , Ltd. | NBW | Class II | 2018-09-19 |
| K181233 | Elecsys FT4 III | Roche Diagnostics | CEC | Class II | 2018-09-18 |
| K181748 | Magnesium | Abbott Laboratories | JGJ | Class I | 2018-09-12 |
| K173568 | NeoBase 2 Non-derivatized MSMS Kit | Wallac Oy, Subsidiary of Perkinelmer, Inc. | NQL | Class II | 2018-09-04 |
| K180866 | CareSens S Fit Blood Glucose Monitoring System | I-Sens, Inc. | NBW | Class II | 2018-08-31 |
| K182057 | EasyMax BT Self-Monitoring Blood Glucose System | Eps Bio Technology Corp. | NBW | Class II | 2018-08-24 |
| K173658 | Confidence Blood Glucose Monitoring System | Applied Biomedical, LLC | NBW | Class II | 2018-08-21 |
| K173638 | Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus | Bionime Corporation | NBW | Class II | 2018-08-17 |
| K180428 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | JGS | Class II | 2018-08-15 |
| K173505 | FORA GTel Blood Glucose Monitoring System | Foracare, Inc. | NBW | Class II | 2018-08-09 |
| K181017 | Free Testosterone AccuBind ELISA Test System | Monobind, Inc. | CDZ | Class I | 2018-07-20 |
| K171566 | Atellica IM High-Sensitivity Troponin I (TNIH) | Siemens Healthcare Diagnostics, Inc. | MMI | Class II | 2018-07-19 |
| K173829 | NeoLSD MSMS kit | Wallac Oy, A Subsidiary of Perkinelmer | PQW | Class II | 2018-07-18 |
| K173327 | DIP/U.S. Urine Analysis Test System | Healthy.Io, Ltd. | JIL | Class II | 2018-07-18 |
| K173797 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | CHL | Class II | 2018-07-17 |
| K173909 | Dimension Hemoglobin A1c Assay | Siemens Healthcare Diagnostics, Inc. | PDJ | Class II | 2018-07-13 |
| K181043 | StatStrip Glucose Hospital Meter System | Nova Biomedical Corporation | PZI | Class II | 2018-07-12 |
| K171274 | ADVIA Centaur High-Sensitivity Troponin I (TNIH) | Siemens Healthcare Diagnostics, Inc. | MMI | Class II | 2018-07-12 |
| K173206 | SEKURE HbA1c Assay | Sekisui Diagnostics P.E.I., Inc. | PDJ | Class II | 2018-07-12 |
| K173511 | ActiveCare TD-4121 Blood Glucose Monitoring System | Taidoc Technology Corporation | NBW | Class II | 2018-07-12 |
| K181201 | Synermed ISE Reagents | Infrared Laboratory Systems, LLC (Dba Synermed) | JGS | Class II | 2018-07-10 |
| K180577 | BioPlex 2200 25-OH Vitamin D Kit | Bio-Rad Laboratories | MRG | Class II | 2018-06-22 |
| K173139 | Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus | Bionime Corporation | NBW | Class II | 2018-06-19 |
| K181316 | POGO Automatic Blood Glucose Monitoring System | Intuity Medical, Inc. | NBW | Class II | 2018-06-14 |
| K172787 | Access hsTnl | Beckman Coulter, Inc. | MMI | Class II | 2018-06-14 |
| K172783 | Access hs Tnl | Beckman Coulter, Inc. | MMI | Class II | 2018-06-12 |
| DEN170043 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | QCC | Class II | 2018-06-12 |
| K172763 | Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder | Zhejiang Kindly Medical Devices Co., Ltd. | JKA | Class II | 2018-06-04 |
| K181082 | ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) | Siemens Healthcare Diagnostics, Inc. | NDY | Class II | 2018-05-25 |
| K180356 | inui In-Home Urine Analysis Test System | Scanadu, Inc. | JIL | Class II | 2018-05-25 |
| K181024 | DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips | DFI Co., Ltd. | JIL | Class II | 2018-05-23 |
| K180771 | Acro HCG Pregnancy Rapid Test | Acro Biotech, Inc. | LCX | Class II | 2018-05-18 |
| K173294 | Magnesium | Abbott Laboratories | JGJ | Class I | 2018-05-18 |
| K180296 | Afinion HbA1c Dx | Alere Technologies AS | PDJ | Class II | 2018-05-07 |
| K173345 | TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System | Taidoc Technology Corporation | JIN | Class I | 2018-05-04 |
| K170901 | ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 | Biosystems S.A. | CIX | Class II | 2018-04-13 |
| K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System | I-Sens, Inc. | JIN | Class I | 2018-04-13 |
| K172201 | Atellica IM Folate Assay | Siemens Healthcare Diagnostics, Inc. | CGN | Class II | 2018-04-12 |
| K172322 | Atellica IM Total hCG (ThCG) | Siemens Healthcare Diagnostics, Inc. | JHI | Class II | 2018-03-29 |
| K180504 | Mission Lipid Panel Monitoring System | ACON Laboratories, Inc. | CHH | Class I | 2018-03-28 |
| K172627 | David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette | Runbio Biotech Co.,Ltd | LCX | Class II | 2018-03-28 |
| DEN170088 | Dexcom G6 Continuous Glucose Monitoring System | Dexcom, Inc. | QBJ | Class II | 2018-03-27 |
| K172723 | Dario LC Blood Glucose Monitoring System | Labstyle Innovation, Ltd. | NBW | Class II | 2018-03-23 |
| K173229 | Preview Digital Pregnancy Test | Guangzhou Wondfo Biotech Co., Ltd. | LCX | Class II | 2018-03-12 |
| K180196 | On Call Express Mobile Blood Glucose Monitoring System | ACON Laboratories, Inc. | NBW | Class II | 2018-03-07 |
| K171476 | SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) | Awareness Technology, Inc. | JGS | Class II | 2018-02-27 |
| K171521 | DUS R-50S (Urine Chemistry system) | DFI Co., Ltd. | JIL | Class II | 2018-02-16 |
| K171861 | CAPILLARYS Hb A1c | Sebia | PDJ | Class II | 2018-02-07 |
| K172512 | ACRO HCG Pregnancy Rapid Test | Acro Biotech, Inc. | LCX | Class II | 2018-02-02 |
| K171971 | Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer | Lite-On Technology Corp. H.S.P.B. | CJE | Class II | 2018-01-25 |
| K171247 | epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test | Epocal, Inc. | CDS | Class II | 2018-01-17 |
| K172992 | Diazyme EZ Vitamin D Assay | Diazyme Laboratories | MRG | Class II | 2018-01-11 |
| K173403 | GEM Premier 5000 | Instrumentation Laboratory CO | CHL | Class II | 2017-12-29 |
| K172257 | TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format) | True Diagnostics, Inc. | JHI | Class II | 2017-12-22 |
| K171480 | NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System | I-Sens, Inc. | NBW | Class II | 2017-12-13 |
| K171771 | ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay | Siemens Healthcare Diagnostics, Inc. | PDJ | Class II | 2017-12-04 |
| K171136 | LIA Pregnancy Test | Lia Diagnostics | LCX | Class II | 2017-11-20 |
| K171482 | NEPHROCHECK Test System | Astute Medical, Inc. | PIG | Class II | 2017-11-16 |
| K170524 | Access AMH | Beckman Coulter, Inc. | PQO | Class II | 2017-11-13 |
| K170464 | StatStrip Xpress Blood Glucose Monitoring System | Nova Biomedical Corporation | NBW | Class II | 2017-11-07 |
| K163087 | PixoTest Blood Glucose Monitoring System | Ixensor Company , Ltd. | NBW | Class II | 2017-11-02 |
| K172133 | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay | Axis-Shield Diagnostics, Ltd. | CDD | Class II | 2017-10-27 |
| K173122 | Abbott Architect Free T4 | Abbott Laboratories | CEC | Class II | 2017-10-27 |
| K170320 | Alinity c ICT Sample Diluent | Abbott Laboratories | CGZ | Class II | 2017-10-24 |
| K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i System | Abbott Laboratories | DHA | Class II | 2017-10-23 |
| K170614 | CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System | I-Sens, Inc. | NBW | Class II | 2017-10-19 |
| K170316 | ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM | Abbott Laboratories | CFR | Class II | 2017-10-19 |
| K160282 | SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System | Sd Biosensor | NBW | Class II | 2017-10-17 |
13,065 clearances in the Clinical Chemistry panel. Data: openFDA.