Review Panel
Clinical Chemistry FDA 510(k) Clearances & Devices
- Cleared Devices
- 13,065
- Product Codes (page)
- 40
- Latest Decision
- 2008-10-10
Clearances · page 19 of 131
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K082680 | LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623 | Siemens Healthcare Diagnostics | JIT | Class II | 2008-10-10 |
| K082486 | GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE | Bayer Healthcare, LLC | NBW | Class II | 2008-10-08 |
| K082618 | ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455 | Taidoc Technology Corporation | NBW | Class II | 2008-10-07 |
| K081478 | RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS | Bionostics, Inc. | JJX | Class I | 2008-10-06 |
| K082562 | APPLIED BIOSYSTEMS 7500 FAST DX | Applied Biosystems, Inc. | NSU | Class II | 2008-09-30 |
| K082645 | DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623 | Siemens Healthcare Diagnostics | NBC | Class II | 2008-09-22 |
| K082395 | GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002 | Bionostics, Inc. | JJX | Class I | 2008-09-18 |
| K081451 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100 | Bionime Corporation | NBW | Class II | 2008-09-18 |
| K082226 | S40 CREATINE KINASE (CK) | Alfa Wassermann Diagnostic Technologies, Inc. | JHS | Class II | 2008-09-18 |
| K082121 | EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005 | Eps Bio Technology Corp. | CGA | Class II | 2008-09-17 |
| K082107 | CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 | Cliniqa Corporation | JJY | Class I | 2008-09-17 |
| K081276 | ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H | Horiba Abx | CFR | Class II | 2008-09-12 |
| K071455 | ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR | Siemens Medical Solutions Diagnostics | MKW | Class II | 2008-09-11 |
| K080751 | ARCHITECT CYCLOSPORINE | Fujirebio Diagnostics,Inc. | MKW | Class II | 2008-09-11 |
| K081450 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110 | Bionime Corporation | NBW | Class II | 2008-09-11 |
| K081789 | DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | JIT | Class II | 2008-09-10 |
| K082036 | LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK | Bio-Rad Laboratories | JJY | Class I | 2008-09-08 |
| K080960 | PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS | Abbott Diabetes Care, Inc. | NBW | Class II | 2008-09-05 |
| K080435 | OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 | Olympus Life Science Research Europa GmbH (Europa) | CIG | Class II | 2008-09-05 |
| K082141 | ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10 | Biokit, S.A. | JIT | Class II | 2008-09-03 |
| K080094 | OLYMPUS TOTAL BHCG TEST SYSTEN | Olympus Life Science Research Europa GmbH (Europa) | DHA | Class II | 2008-09-03 |
| K081731 | DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32 | Siemens Healthcare Diagnostics | CGS | Class II | 2008-08-29 |
| K081726 | TYSONBIO LINK HEALTH MANAGEMENT SYSTEM | Tyson Bioresearch, Inc. | NBW | Class II | 2008-08-26 |
| K082067 | MSC LIPID CONTROL | Maine Standards Co. | JJY | Class I | 2008-08-22 |
| K080643 | ELECSYS ANTI-TSHR CALCHECK | Roche Diagnostics | JJX | Class I | 2008-08-22 |
| K082099 | VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905 | Ortho-Clinical Diagnostics, Inc. | CGZ | Class II | 2008-08-21 |
| K081875 | GENTIAN CYSTATIN C IMMUNOASSAY | Gentian AS | NDY | Class II | 2008-08-20 |
| K080641 | TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81 | Home Diagnostics, Inc. | NBW | Class II | 2008-08-19 |
| K080710 | TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81 | Home Diagnostics, Inc. | NBW | Class II | 2008-08-13 |
| K081915 | FDTX GLUCOSE CONTROL SOLUTION | Fujirebio Diagnostics Texas, Inc. | JJX | Class I | 2008-08-08 |
| K080167 | ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS | Siemens Healthcare Diagnostics | CEC | Class II | 2008-08-08 |
| K080273 | AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION | Fujirebio Diagnostics Texas, Inc. | JJX | Class I | 2008-08-08 |
| K071649 | NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B | Wallac OY | JIA | Class I | 2008-08-07 |
| K081992 | DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 | Siemens Healthcare Diagnostics, Inc. | MKW | Class II | 2008-08-05 |
| K081957 | U-RIGHT TD-4247 BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | NBW | Class II | 2008-08-05 |
| K081319 | DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56 | Siemens Healthcare Diagnostics, Inc. | JIT | Class II | 2008-08-04 |
| K080370 | ABL 80 CO-OX SYSTEM | Sendx Medical, Inc. | CHL | Class II | 2008-07-31 |
| K080552 | CYTO-CHEX BCT | Streck | GIM | Class II | 2008-07-31 |
| K080995 | MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM | Affymetrix, Inc. | NSU | Class II | 2008-07-30 |
| K080468 | LIASYS WITH MODELS LIASYS | Ams S.R.L. Analyzer Medical System | CFR | Class II | 2008-07-25 |
| K081403 | GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK | Bionostics, Inc. | JJX | Class I | 2008-07-25 |
| K081714 | FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM | Taidoc Technology Corporation | CGA | Class II | 2008-07-25 |
| K063841 | NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS | Liposcience | MRR | Class I | 2008-07-23 |
| K081229 | SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING | Smiths Medical Asd, Inc. | JKA | Class II | 2008-07-21 |
| K063662 | RAMP NT-PROBNP ASSAY | Response Biomedical Corp. | NBC | Class II | 2008-07-21 |
| K073030 | AG-605 BLOOD GLUCOSE MONITORING SYSTEM | Andon Health Co, Ltd. | NBW | Class II | 2008-07-21 |
| K080125 | APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 | Wako Chemicals USA, Inc. | LBS | Class I | 2008-07-18 |
| K080123 | APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 | Wako Chemicals USA, Inc. | CFR | Class II | 2008-07-17 |
| K072977 | DIAZYME APOLIPOPROTEIN A-1 ASSAY | General Atomics | MSJ | Class I | 2008-07-16 |
| K081389 | ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM | Roche Diagnostics | NBW | Class II | 2008-07-15 |
| K072143 | S40 CLINICAL ANALYZER, S TEST ALB | Alfa Wassermann Diagnostic Technologies, Inc. | CIX | Class II | 2008-07-14 |
| K081345 | AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY) | Thermogenesis Corp. | JQC | Class I | 2008-07-10 |
| K081683 | LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 | Siemens Healthcare Diagnostics | JIT | Class II | 2008-07-07 |
| K080538 | IDEAL LIFE POD (MODEL ILP 0001) | Ideal Life, Inc. | NBW | Class II | 2008-07-03 |
| K081643 | DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 | Siemens Healthcare Diagnostics | MMI | Class II | 2008-07-03 |
| K081609 | CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237 | Taidoc Technology Corporation | CGA | Class II | 2008-07-02 |
| K081300 | DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics | JHM | Class I | 2008-07-02 |
| K080073 | S-TEST CREATININE (CRE) | Alfa Wassermann, Inc. | JFY | Class II | 2008-06-30 |
| K081411 | VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 | Ortho-Clinical Diagnostics, Inc. | JGS | Class II | 2008-06-30 |
| K072854 | DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM | Tyson Bioresearch, Inc. | NBW | Class II | 2008-06-30 |
| K080283 | IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | NBW | Class II | 2008-06-27 |
| K073537 | NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 | Siemens Medical Solutions Diagnostics | MQM | Class I | 2008-06-27 |
| K072142 | S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST | Alfa Wassermann Diagnostic Technologies, Inc. | CKF | Class II | 2008-06-26 |
| K073223 | S-TEST C02 | Alfa Wassermann Diagnostic Technologies, Inc. | KHS | Class II | 2008-06-26 |
| K081533 | SENTINEL PLASMAPROTEINS CAL 3X | SENTINEL CH. SpA | JIX | Class II | 2008-06-25 |
| K072140 | S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU | Alfa Wassermann Diagnostic Technologies, Inc. | CFR | Class II | 2008-06-24 |
| K072141 | S40 CLINICAL ANALYZER, S TEST IP, S TEST UA | Alfa Wassermann Diagnostic Technologies, Inc. | CEO | Class I | 2008-06-24 |
| K072356 | S-TEST CA | Alfa Wassermann Diagnostic Technologies, Inc. | CJY | Class II | 2008-06-24 |
| K081144 | CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243 | Taidoc Technology Corporation | NBW | Class II | 2008-06-23 |
| K080811 | TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET | Roche Diagnostics Corp. | NDY | Class II | 2008-06-20 |
| K073634 | MULTIGENT CREATININE (ENZYMATIC) ASSAY | SENTINEL CH. SpA | JFY | Class II | 2008-06-19 |
| K073416 | ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM | Arkray Factory USA, Inc. | CGA | Class II | 2008-06-13 |
| K081318 | ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM | Lifescan, Inc. | NBW | Class II | 2008-06-09 |
| K080014 | CLEVER CHEK TD-3250C BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM | Taidoc Technology Corporation | NBW | Class II | 2008-06-09 |
| K080269 | TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS | Biosite Incorporated | NBC | Class II | 2008-06-06 |
| K080384 | HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER | The Binding Site, Ltd. | NDY | Class II | 2008-06-06 |
| K080973 | CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC | Cliniqa Corporation | JJY | Class I | 2008-06-02 |
| K073295 | UREA/BUN, SCAL, NORTROL, ABTROL | Thermofisher Scientific OY | CDQ | Class II | 2008-05-29 |
| K081074 | DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691 | Siemens Healthcare Diagnostics, Inc. | JLW | Class II | 2008-05-23 |
| K073612 | URIC ACID (AOX), SCAL, NORTROL, ABTROL | Thermofisher Scientific OY | JIX | Class II | 2008-05-23 |
| K081103 | LOCI THYROID CALIBRATOR WITH MODEL RC610 | Siemens Healthcare Diagnostics, Inc. | JIX | Class II | 2008-05-23 |
| K080578 | DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA | Siemens Healthcare Diagnostics, Inc. | NBC | Class II | 2008-05-16 |
| K080662 | GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR | Genzyme Corporation | NDY | Class II | 2008-05-15 |
| K080607 | CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160 | Roche Diagnostics Corp. | JIX | Class II | 2008-05-12 |
| K073370 | TC MATRIX CLINICAL CHEMISTRY ANALYZER | Teco Diagnostics | JJE | Class I | 2008-05-08 |
| K070104 | PROLYTE ELECTROLYTE ANALYZER | Diamond Diagnostics, Inc. | JGS | Class II | 2008-05-07 |
| K072536 | ESA BIOSCIENCES INC. VITAMIN D HPLC TEST | Esa Biosciences, Inc. | MRG | Class II | 2008-05-07 |
| K073640 | ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS | Axis-Shield Diagnostics, Ltd. | LPS | Class II | 2008-04-24 |
| K080501 | SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240 | Taidoc Technology Corporation | NBW | Class II | 2008-04-21 |
| K073231 | ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM | Lifescan, Inc. | NBW | Class II | 2008-04-18 |
| K072548 | CREATINE KINASE LIQUID REAGENT, MODEL C519-440 | Teco Diagnostics | CGS | Class II | 2008-04-18 |
| K072905 | 3TEST SUPREME GLUCOSE MONITORING SYSTEM | Neuero Engineering, Inc. | NBW | Class II | 2008-04-18 |
| K073497 | HDL CHOLESTEROL REAGENT, MODEL 10211 | Medica Corp. | LBS | Class I | 2008-04-14 |
| K070889 | AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 | Wallac OY | CGZ | Class II | 2008-04-14 |
| K072458 | GBI TSH NEONATAL SCREENING KIT | Golden Bridge International, Inc. | JLW | Class II | 2008-04-10 |
| K073648 | GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1 | Apex BioTechnology Corp. | CGA | Class II | 2008-04-10 |
| K073492 | DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM | Tyson Bioresearch, Inc. | NBW | Class II | 2008-04-08 |
| K063437 | ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 | Monobind, Inc. | JLW | Class II | 2008-04-04 |
| K073494 | CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING | Taidoc Technology Corporation | NBW | Class II | 2008-04-02 |
| K073137 | GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1 | Apex BioTechnology Corp. | NBW | Class II | 2008-04-01 |
13,065 clearances in the Clinical Chemistry panel. Data: openFDA.