meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
30
Latest Decision
2010-04-27

Clearances · page 17 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K094031 ELECSYS FOLATE III CALCHECK 5 Roche Diagnostics JJX Class I 2010-04-27
K092911 SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER Diazyme Laboratories JJX Class I 2010-04-26
K100810 ELECSYS C-PEPTIDE CALCHECK 5 Roche Diagnostics JJX Class I 2010-04-26
K093421 ELECSYS TESTOSTERONE II IMMUNOASSAY Roche Diagnostics Corp. CDZ Class I 2010-04-23
K093940 ADVOCATE REDI-CODE DASH BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4276 Taidoc Technology Corporation NBW Class II 2010-04-23
K093836 ELECSYS TSH CALCHECK 5 Roche Diagnostics JJX Class I 2010-04-15
K093611 VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002; Ortho-Clinical Diagnostics, Inc. KHS Class II 2010-04-15
K100747 CONTREX PLUS LOW CONTROL SOLUTION Apex BioTechnology Corp. JJX Class I 2010-04-14
K093680 DIAZYME CYSTATIN C ASSAY Diazyme Laboratories NDY Class II 2010-04-08
K100701 SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277 Biotest Medical Corp. NBW Class II 2010-04-08
K100673 EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020 Medica Corp. JGS Class II 2010-04-06
K093555 COBAS U411 TEST SYSTEM Roche Diagnostics KQO Class I 2010-04-02
K093506 CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267 Taidoc Technology Corporation CGA Class II 2010-04-01
K100594 ELECSYS TROPONIN I CALCHECK 5 Roche Diagnostics JJX Class I 2010-04-01
K092849 BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER Epocal, Inc. CEM Class II 2010-03-30
K093582 ELECSYS CK-MB CALCHECK 5 Roche Diagnostics JJX Class I 2010-03-29
K093941 CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265 Taidoc Technology Corporation CGA Class II 2010-03-26
K093732 ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770 Siemens Healthcare Diagnostics JIX Class II 2010-03-22
K092848 ELECSYS TROPONIN T CALCHECK 5 Roche Diagnostics Corp. JJX Class I 2010-03-19
K100293 ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810 Siemens Heatlhcare Diagnostics, Inc. JIT Class II 2010-03-19
K093492 MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR Diamond Diagnostics, Inc. JJY Class I 2010-03-19
K091555 MODEL TD-3252 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM Taidoc Technology Corporation NBW Class II 2010-03-15
K093930 DIDGET WORLD REPORTS Bayer Healthcare, LLC NBW Class II 2010-03-12
K091975 INTEGRATED LABORATORY AUTOMATION SOLUTION Integrated Laboratory Automation Solutions, Inc. CGA Class II 2010-03-10
K093384 MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3) Diamond Diagnostics, Inc. JJY Class I 2010-03-10
K090123 NEONATAL BIOTINIDASE KIT, MODEL 3018 Perkinelmer, Inc. NAK Class II 2010-03-05
K093645 EXL ANEM CAL, MODEL RC640 Siemens Healthcare Diagnostics JIX Class II 2010-03-05
K092740 ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 Abbott Laboratories CGN Class II 2010-03-05
K093700 ELECSYS HCG STAT CALCHECK 5 Roche Diagnostics Corp. JJX Class I 2010-03-04
K093764 SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM Biotest Medical Corp. NBW Class II 2010-03-02
K092902 U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC Taidoc Technology Corporation NBW Class II 2010-03-02
K093592 ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223 Taidoc Technology Corporation NBW Class II 2010-02-25
K093475 BASESENS BLOOD GLUCOSE MONITORING SYSTEM Hygeia, Inc. NBW Class II 2010-02-24
K092894 EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM Eps Bio Technology Corp. NBW Class II 2010-02-24
K093789 INTOUCH DIABETES Symcare Personalized Health Solutions, Inc. NBW Class II 2010-02-19
K093318 ACCELERATOR APS Abbott Laboratories CEM Class II 2010-02-19
K093712 FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM Taidoc Technology Corporation NBW Class II 2010-02-19
K093635 MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS Taidoc Technology Corporation NBW Class II 2010-02-18
K093631 B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644 Siemens Healthcare Diagnostics CDD Class II 2010-02-12
K093005 FORA G72 BLODO GLUCOSE MONITORING SYSTEM/TD-4264 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4264 Taidoc Technology Corporation NBW Class II 2010-02-05
K092649 ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190 Roche Diagnostics Corp. NBC Class II 2010-02-04
K090609 OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM Ok Biotech Co., Ltd. NBW Class II 2010-02-04
K093972 BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706 Becton, Dickinson & CO JKA Class II 2010-01-21
K091765 EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM Visgeneer, Inc. NBW Class II 2010-01-19
K091547 NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS Nova Biomedical Corp. NBW Class II 2010-01-15
K091867 ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773 Siemens Healthcare Diagnostics CDZ Class I 2010-01-14
K093035 FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244 Taidoc Technology Corporation NBW Class II 2009-12-24
K093098 AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM Arkray, Inc. KQO Class I 2009-12-23
K092169 ELECSYS PROBNP II CALCHECK 5 Roche Diagnostics JJX Class I 2009-12-16
K090940 SPOTCHECK BLOOD SPOT CONTROL, ASSAYED Astoria-Pacific, Inc. JJT Class I 2009-12-14
K093498 LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913 DiaSorin, Inc. JJX Class I 2009-12-14
K092099 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254 Taidoc Technology Corporation NBW Class II 2009-12-10
K082683 SD CHECK GOLD Standard Diagnostics, Inc. NBW Class II 2009-12-08
K082965 DS-A BLOOD GLUCOSE MONITORING SYSTEM Alliance International Co., Ltd. CGA Class II 2009-12-07
K092603 COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY Roche Diagnostics CFR Class II 2009-12-04
K090628 DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 Bayer Healthcare, LLC NBW Class II 2009-12-04
K093458 SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 Beckman Coulter, Inc. JFY Class II 2009-12-04
K092749 MAS AND MINI-TROL PTH CONTROL Microgenics Corporation JJX Class I 2009-12-03
K090405 LIPIDPRO SYSTEM Infopia Co, Ltd. NBW Class II 2009-12-01
K092104 ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM Arkray Factory USA, Inc. CGA Class II 2009-11-24
K091814 FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE Taidoc Technology Corporation CGA Class II 2009-11-20
K092993 ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL Siemens Healthcare Diagnostics JJX Class I 2009-11-20
K083273 MICRODOT XTRA Cambridge Sensors Limited NBW Class II 2009-11-19
K091157 GLUCO LAB AUTO CODING, MODEL IGM-0022 Infopia Co, Ltd. NBW Class II 2009-11-17
K092737 EASYRA MG REAGENT, MODEL 10220 Medica Corp. JGJ Class I 2009-11-17
K091815 SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 Biotest Medical Corp. NBW Class II 2009-11-16
K092168 ELECSYS HCG+B CALCHECK 5 Roche Diagnostics JJX Class I 2009-11-16
K092113 STA - FREE PS CALIBRATOR Diagnostica Stago, Inc. JIX Class II 2009-11-13
K093032 TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET Biosite Incorporated JJY Class I 2009-11-13
K092888 ELECSYS TOXO IGG CALCHECK 5 Roche Diagnostics Corp. JJX Class I 2009-11-10
K091914 OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION Bionostics, Inc. JJX Class I 2009-11-06
K092320 ELECSYS PRECICONTROL THYROAB Roche Diagnostics JJY Class I 2009-11-03
K092585 ELECSYS RUBELLA IGGA CALCHECK 5 Roche Diagnostics JJX Class I 2009-10-30
K091413 S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG) Alfa Wassermann, Inc. CHH Class I 2009-10-26
K091102 ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS Arkray Factory USA, Inc. CGA Class II 2009-10-23
K092887 EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009 Eps Bio Technology Corp. NBW Class II 2009-10-21
K090703 POLY-CHEM 90 GLUCOSE Polymedco, Inc. CFR Class II 2009-10-20
K091846 SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 Beckman Coulter, Inc. JFJ Class II 2009-10-16
K092570 ABX PENTRA TPU CAL, MODEL A11A01898 HORIBA ABX SAS JIT Class II 2009-10-16
K091216 CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797 Siemens Healthcare Diagnostics JIL Class II 2009-10-09
K090653 POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM Arkray Factory USA, Inc. NBW Class II 2009-10-09
K090712 EOCENE SYSTEM Infopia Co, Ltd. NBW Class II 2009-10-02
K091332 AIA-PACK RBC FOLATE Tosoh Bioscience, Inc. CGN Class II 2009-10-02
K091910 PICCOLO MAGNESIUM TEST SYSTEM Abaxis, Inc. JGJ Class I 2009-10-01
K091601 ELECYS ANTI-CCP CALCHECK Roche Diagnostics Corp. JJX Class I 2009-09-25
K092051 THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158 Microgenics Corp. JJY Class I 2009-09-21
K091898 BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234 Taidoc Technology Corporation NBW Class II 2009-09-18
K092506 EASYRA GLU-H REAGENT, MODEL 10200 Medica Corp. CFR Class II 2009-09-16
K091544 S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 Alfa Wassermann, Inc. CFJ Class II 2009-09-09
K090104 LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603 DiaSorin, Inc. JJX Class I 2009-09-09
K092645 FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 Fujirebio Diagnostics,Inc. JJX Class I 2009-09-05
K091991 EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200 Medica Corp. CIG Class II 2009-09-04
K091861 VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927 Ortho-Clinical Diagnostics, Inc. JGS Class II 2009-09-03
K090846 GSP INSTRUMENT AND GSP NEONATAL HTSH KIT Perkinelmer, Inc. JLW Class II 2009-09-03
K083744 BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 Binax, Inc. MJZ Class I 2009-09-01
K091287 VS-SENSE TEST Common Sense , Ltd. CEN Class I 2009-08-31
K083867 ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND Beckman Coulter, Inc. CDZ Class I 2009-08-27
K091820 CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM Bayer Healthcare NBW Class II 2009-08-26
K091292 BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 Becton, Dickinson and Company (BD) JKA Class II 2009-08-25
K082699 ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS Roche Diagnostics MMI Class II 2009-08-19

13,065 clearances in the Clinical Chemistry panel. Data: openFDA.