meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
40
Latest Decision
2012-04-24

Clearances · page 14 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K120664 PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM Abaxis, Inc. JGY Class I 2012-04-24
K120662 PICCOLO HDL-CAPILLARY TEST SYSTEM Abaxis, Inc. JHM Class I 2012-04-24
K103230 AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION Bestgen Biotech Corp. CGA Class II 2012-04-24
K112315 HOME PREGNANCY TEST Newscen Coast Bio-Pharmaceutical Co., Ltd. JHI Class II 2012-04-23
K120591 DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 Diamond Diagnostics, Inc. JIT Class II 2012-04-17
K103037 IND URINARY TRACT INFECTION (UTI) TEST STRIPS Ind Diagnostic, Inc. NGJ Class I 2012-04-17
K113768 U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM Taidoc Technology Corporation LFR Class II 2012-04-12
K112653 ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS ACON Laboratories, Inc. JJX Class I 2012-04-09
K120448 MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL Apex BioTechnology Corp. CGA Class II 2012-04-06
K111664 DIAZYME CYSTATIN C POC TEST KIT Diazyme Laboratories NDY Class II 2012-03-30
K112538 ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT Alfa Wassermann Diagnostic Technologies, Inc. CHH Class I 2012-03-29
K120568 FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM Abbott Diabetes Care, Inc. NBW Class II 2012-03-29
K110737 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 Bionime Corporation NBW Class II 2012-03-29
K110894 CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER Bayer Healthcare LFR Class II 2012-03-28
K110587 CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) Bayer Healthcare, LLC LFR Class II 2012-03-28
K112834 MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES Verichem Laboratories, Inc. JIX Class II 2012-03-28
K113243 EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM Eps Bio Technology Corp. LFR Class II 2012-03-28
K113547 GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL Apex BioTechnology Corp. CGA Class II 2012-03-28
K112377 BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER Shenzhen Mindray Bio-Medical Electronics Co., Ltd. CFR Class II 2012-03-23
K110520 BIOLIS 12I Tokyo Boeki Medisys, Inc. CEM Class II 2012-03-23
K120197 ABL90 FLEX Radiometer Medical Aps CHL Class II 2012-03-19
K103116 AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM Bestgen Biotech Corp. CGA Class II 2012-03-13
K103329 DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION Delbio Incorporation NBW Class II 2012-03-13
K110761 MICT TSH Magnabiosciences, LLC JLW Class II 2012-03-09
K112638 NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS Nova Biomedical Corporation NBW Class II 2012-03-09
K113131 LIASYS 450 Ams CFR Class II 2012-03-08
K111268 CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM Bayer Healthcare LFR Class II 2012-03-06
K120124 FORESIGHT U120 URINE ANALYZER ACON Laboratories, Inc. JIL Class II 2012-03-06
K111964 AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY Aalto Scientific, Ltd. JJY Class I 2012-03-02
K111456 MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM Tianjin Empecs Medical Device Co., Ltd. NBW Class II 2012-02-28
K113007 BIONIME DIABETES MANAGEMENT SYSTEM VI.0 Bionime Corporation JQP Class I 2012-02-27
K111874 FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS Abbott Laboratories LFR Class II 2012-02-16
K111938 IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL... Immunodiagnostic Systems , Ltd. JJX Class I 2012-02-14
K103044 AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION Bestgen Biotech Corp. NBW Class II 2012-02-10
K113343 DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM Delbio Incorporation NBW Class II 2012-02-08
K113319 ROTOR-GENE Q MDX QIAGEN GmbH OOI Class II 2012-02-06
K111890 FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM Taidoc Technology Corporation NBW Class II 2012-02-06
K103325 IDS-ISYS INTACT PTH Immunodiagnostic Systems , Ltd. CEW Class II 2012-02-03
K112143 AUDIT MICROCV T-UPTAKE LINEARITY Aalto Scientific, Ltd. JJX Class I 2012-01-31
K113764 GLUCOSE METER-CHECK SOLUTION FOR INFOPIA Bionostics, Inc. JJX Class I 2012-01-30
K113524 VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT Maine Standards Co. JJX Class I 2012-01-27
K102383 MICRODOT & MICRODOT XTRA Cambridge Sensors Limited NBW Class II 2012-01-27
K113208 GAL-1A BLOOD GLUCOSE MONITORING SYSTEM Apex BioTechnology Corp. CGA Class II 2012-01-26
K112705 AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL Aalto Scientific, Ltd. JJY Class I 2012-01-24
K110534 RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3 Randox Laboratories Limited JJY Class I 2012-01-23
K112161 AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE.. Radiometer Medical Aps KHO Class I 2012-01-20
K112725 LIAISON 25 OH VITAMIN D TOTAL ASSAY DiaSorin, Inc. MRG Class II 2012-01-20
K110017 AG-608N BLOOD GLUCOSE MONITORING SYSTEM Andon Medical Co., Ltd. NBW Class II 2012-01-18
K113098 AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III Apex BioTechnology Corp. NBW Class II 2012-01-17
K100437 AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION Bestgen Biotech Corp. NBW Class II 2012-01-12
K113137 GLUCOSE TEST SYSTEM Roche Diagnostics NBW Class II 2012-01-06
K112955 NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM Nova Biomedical Corporation KHP Class I 2012-01-05
K113373 DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL Siemens Healthcare Diagnostics, Inc. JIT Class II 2011-12-30
K113269 ELITTECH CLINICAL SYSTEMS ALP IFCC SL Elitechgroup CJE Class II 2011-12-29
K112412 AU5800(R) CHEMISTRY ANALYZER Beckman Coulter, Inc. CEM Class II 2011-12-23
K112901 EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM Eps Bio Technology Corp. LFR Class II 2011-12-23
K112352 GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT Bionostics, Inc. JJX Class I 2011-12-23
K112430 I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE Abbott Pont of Care, Inc. KHP Class I 2011-12-20
K101926 FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM Taidoc Technology Corporation NBW Class II 2011-12-20
K112443 ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) Axis-Shield Diagnostics, Ltd. CDD Class II 2011-12-19
K112275 FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM Taidoc Technology Corporation NBW Class II 2011-12-15
K111753 HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE Hitachi Chemical Diagnostics, Inc. CHH Class I 2011-12-14
K111452 PRESAGE ST2 ASSAY Critical Care Diagnostics, Inc. (Dba Critical Diag OYG Class II 2011-12-09
K103544 IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D Agamatrix, Inc. NBW Class II 2011-12-07
K110701 ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 DNA Genotek, Inc. OYJ Class II 2011-12-02
K110786 ESENSOR WARFARIN SENSITIVITY SALIVA TEST GenMark Diagnostics, Inc. NSU Class II 2011-12-02
K111915 MAGNESIUM ASSAY Sekisui Diagnostics P.E.I., Inc. JGJ Class I 2011-12-02
K103531 PRESTIGE 24I; BIOLIS 24I; MGC 240 Tokyo Boeki Medisys, Inc. CFR Class II 2011-12-01
K112337 RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL Randox Laboratories, Ltd. JJY Class I 2011-12-01
K111335 ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 Tosoh Bioscience, Inc. CKG Class II 2011-12-01
K110605 ROM PLUS Clinical Innovations, LLC NQM Class I 2011-11-23
K110619 ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS Biokit, S.A. MRG Class II 2011-11-23
K112963 TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS Taidoc Technology Corporation NBW Class II 2011-11-22
K112999 DIMENSION CLINICAL CHEMISTRY SYSTEM Siemens Healthcare Diagnostics JJE Class I 2011-11-22
K111960 ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS Elitechgroup KHS Class II 2011-11-18
K103376 ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL Seppim S.A.S. JFY Class II 2011-11-18
K111932 IGLUCOSE SYSTEM Positiveid Corporation NBW Class II 2011-11-10
K111509 SWEETSPOT DIABETES DATA MANAGEMENT SERVICE Sweetspot Diabetes Care, Inc. NBW Class II 2011-11-09
K112416 CPK REAGENT Vital Diagnostics (Manufacturing) Ptyltd CGS Class II 2011-11-09
K111356 ASIMANAGER - AT Arlington Scientific, Inc. JQT Class I 2011-11-09
K103788 PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT HORIBA ABX SAS CFR Class II 2011-11-08
K101863 IT/IF CONTROL Sebia JJY Class I 2011-11-07
K112603 ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS Beckman Coulter, Inc. JJX Class I 2011-11-04
K112408 POLY-CHEM 90 ISE MODULE Polymedco, Inc. CEM Class II 2011-11-04
K103021 ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM Infopia Co, Ltd. NBW Class II 2011-11-04
K110738 THERMO SCIENTIFIC MAS OMNI-CORE Microgenics Corporation JJY Class I 2011-11-03
K103278 ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION I-Sens, Inc. CGA Class II 2011-10-28
K112788 EASTLYTE NA/K/CA/PH Medica Corp. CEM Class II 2011-10-20
K112528 ELECSYS T4 CALCHECK 5 Roche Diagnostics Corporation JJX Class I 2011-10-18
K110586 ADVIA CENTAUR VITAMIN D TOTAL ASSAY Siemens Healthcare Diagnostics, Inc. MRG Class II 2011-10-14
K103115 PRODIGY DIABETES MANAGEMENT SOFTWARE Prodigy Diabetes Care, LLC NBW Class II 2011-10-12
K102063 HEALTH-E-CONNECT SYSTEM Alr Technologies NBW Class II 2011-10-11
K102316 GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM Broadmaster Biotech Corporation CGA Class II 2011-10-07
K110780 ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II Elitechgroup CIG Class II 2011-10-07
K111371 ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM ACON Laboratories, Inc. CGA Class II 2011-10-06
K110579 ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS Abbott Laboratories CDD Class II 2011-10-06
K103487 FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST Taidoc Technology Corporation LCX Class II 2011-10-04
K110846 RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 Randox Laboratories Limited JJW Class I 2011-09-30
K110904 RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3 Randox Laboratories, Ltd. JJY Class I 2011-09-30
K112738 ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE Andon Medical Co., Ltd. NBW Class II 2011-09-30

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