meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
45
Latest Decision
2004-03-25

Clearances · page 27 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K040226 WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET Wako Chemicals USA, Inc. JIT Class II 2004-03-25
K040670 MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL Home Diagnostics, Inc. NBW Class II 2004-03-25
K040628 PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM Abbott Laboratories NBW Class II 2004-03-25
K040245 CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC) Roche Diagnostics Corp. JIX Class II 2004-03-24
K040181 ACCESS DHEA-S REAGENT ASSAY Beckman Coulter, Inc. JKC Class I 2004-03-24
K032657 TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH) Home Diagnostics, Inc. NBW Class II 2004-03-24
K040631 VITALAB DIRECT BILIRUBIN REAGENT Clinical Data, Inc. CIG Class II 2004-03-18
K033297 ZAP HCG TEST, MODEL 8001 Zbx Corporation JHI Class II 2004-03-18
K040351 RANDOX LIQUID CRP CONTROLS Randox Laboratories, Ltd. JJX Class I 2004-03-12
K032936 DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR Stanbio Laboratory JIX Class II 2004-03-12
K040280 PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS Roche Diagnostics Corp. JJY Class I 2004-03-11
K040534 VITALAB AMYLASE REAGENT Clinical Data, Inc. JFJ Class II 2004-03-11
K032932 DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR Stanbio Laboratory LBS Class I 2004-03-10
K034000 VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR Clinical Data, Inc. CDT Class I 2004-03-10
K033921 AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 Diagnostic Chemicals , Ltd. JIF Class I 2004-03-10
K040471 OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024 Olympus America, Inc. JIT Class II 2004-03-10
K040277 LIQUICHEK CARDIAC MARKER CONTROL LT Bio-Rad Laboratories, Inc. JJY Class I 2004-03-10
K034048 R&D GLU-LINE HEMATOLOGY CONTROL R&D Systems, Inc. JJX Class I 2004-03-10
K040508 VITALAB MAGNESIUM REAGENT Clinical Data, Inc. JGJ Class I 2004-03-08
K040467 VITALAB URIC ACID REAGENT Clinical Data, Inc. KNK Class I 2004-03-08
K040341 CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST Unipath , Ltd. LCX Class II 2004-03-08
K040329 MODIFICATION TO E.P.T. PREGNANCY TEST Unipath , Ltd. LCX Class II 2004-03-08
K040455 LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS Cliniqa Corporation JJX Class I 2004-03-05
K040273 LYPHOCHEK ASSAYED CHEMISTRY CONTROL Bio-Rad Laboratories, Inc. JJY Class I 2004-03-04
K033060 CALIBRATING MATERIAL, CALIBRATING STANDARDS Diamond Diagnostics, Inc. JIT Class II 2004-03-04
K040025 A1C-CELLULAR Streck Laboratories, Inc. JJX Class I 2004-03-02
K033851 DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G) Hypoguard USA, Inc. JIL Class II 2004-03-02
K033278 RANDOX URIC ACID Randox Laboratories, Ltd. CDO Class I 2004-02-27
K033786 LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA Ibl GmbH JIT Class II 2004-02-27
K040157 ELECSYS C-PEPTIDE CALCHECK Roche Diagnostics Corp. JJX Class I 2004-02-25
K040091 LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS Cliniqa Corporation JJY Class I 2004-02-23
K033731 AXSYM CORTISOL ASSAY Fujirebio Diagnostics,Inc. JFT Class II 2004-02-20
K033791 BAYER SPECIFIC PROTEIN REFERENCE SERUM Bayer Healthcare, LLC JIX Class II 2004-02-13
K033873 ELECSYS C-PEPTIDE CALSET Roche Diagnostics Corp. JIX Class II 2004-02-13
K033426 LIAISON N-TACT PTH DiaSorin, Inc. CEW Class II 2004-02-12
K032844 LIAISON 25 OH VITAMIN D DiaSorin, Inc. MRG Class II 2004-02-12
K033706 POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS Polymedco, Inc. LPS Class II 2004-02-04
K030849 AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1 N-Dia, Inc. JJX Class I 2004-02-02
K033606 ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST Axis-Shield Diagnostics, Ltd. NBC Class II 2004-01-30
K033056 BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT Diamond Diagnostics, Inc. CDS Class II 2004-01-30
K032199 ESA PLASMA FREE METANEPHRINE ANALYSIS KIT Esa, Inc. CHQ Class I 2004-01-30
K033058 CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS Diamond Diagnostics, Inc. CGX Class II 2004-01-30
K033055 GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS Diamond Diagnostics, Inc. CGA Class II 2004-01-30
K040115 PICCOLO MAGNESIUM TEST SYSTEM Abaxis, Inc. JGJ Class I 2004-01-30
K033910 OLYMPUS URINE CALIBRATOR Cliniqa Corporation JIX Class II 2004-01-30
K030655 HOLOTC RIA Axis-Shield Biochemicals, Asa CDD Class II 2004-01-29
K032235 MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST Biosite Incorporated NBC Class II 2004-01-28
K033302 NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040 Nichols Institute Diagnostics CEW Class II 2004-01-26
K034055 IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I Diagnostic Products Corp. JHX Class II 2004-01-21
K033344 LIGAND PLUS CONTROL LEVEL 1-3 Consolidated Technology JJY Class I 2004-01-16
K033658 E.P.T. PREGNANCY TEST Unipath , Ltd. LCX Class II 2004-01-16
K033155 BIOCENTREX CARDIAC PANEL Biocentrex MYT Class II 2004-01-12
K033643 CO2 CALIBRATOR/DILUENT Bayer Healthcare, Diagnostics Division JIT Class II 2004-01-08
K033845 PRECISION XCEED DIABETES MONITORING SYSTEM Abbott Laboratories NBW Class II 2004-01-08
K033937 ELECSYS PRECICONTROL MULTIANALYTE Roche Diagnostics Corp. JJY Class I 2004-01-07
K033433 NOVA GLUCOSE CONTROL SOLUTIONS Nova Biomedical Corp. JJX Class I 2004-01-02
K033487 STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI Dade Behring, Inc. MMI Class II 2003-12-24
K033383 TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200 Biosite Incorporated NBC Class II 2003-12-23
K032563 CLINITEST HCG PREGNANCY TEST Bayer Healthcare, LLC JHI Class II 2003-12-23
K033379 BAYER SPECIAL CHEMISTRY CONTROLS Bayer Diagnostics Corp. JJY Class I 2003-12-19
K031260 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 Abbott Diabetes Care, Inc. NBW Class II 2003-12-19
K033603 INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 Beckman Coulter, Inc. LIG Class II 2003-12-19
K031947 BAYER CLINITEK STATUS ANALYZER Bayer Healthcare, LLC KQO Class I 2003-12-19
K032029 BTG SMARTEST GLUCOSE TEST SYSTEM Bt Medical NBW Class II 2003-12-18
K033734 LIGHTCYCLER INSTRUMENT VERSION 1.2 Roche Diagnostics Corp. JJF Class I 2003-12-17
K031560 BAYER RAPIDLAB 1200 SYSTEM Bayer Healthcare, LLC CHL Class II 2003-12-17
K033380 BAYER SPECIAL CHEMISTRY CALIBRATORS Bayer Diagnostics Corp. JIX Class II 2003-12-16
K033234 IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER Diagnostic Products Corp. DHA Class II 2003-12-12
K033063 MISSION CONTROLS Diamond Diagnostics, Inc. JJS Class I 2003-12-12
K033610 HDL-CHOLESTEROL PLUS 2ND GENERATION Roche Diagnostics Corp. LBS Class I 2003-12-05
K024014 RANDOX RX DAYTONA Randox Laboratories, Ltd. CGA Class II 2003-12-04
K033387 QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 Bio-Rad JJY Class I 2003-12-02
K032992 UNIMARK HOME PREGNANCY TEST DEVICE Biotech Atlantic, Inc. LCX Class II 2003-11-21
K033041 ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP ACON Laboratories, Inc. LCX Class II 2003-11-21
K032665 OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071 Olympus America, Inc. JIX Class II 2003-11-21
K033501 MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS) Roche Diagnostics Corp. JIX Class II 2003-11-20
K032753 GLUCOSE TOLERANCE BEVERAGE Perk Scientific, Inc. MRV Class II 2003-11-18
K032987 ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005 Unotech Diagnostics, Inc. JHI Class II 2003-11-17
K031798 GOOD MORNING TEST Standard Diagnostics, Inc. LCX Class II 2003-11-12
K032646 ELECSYS PROBNP IMMUNOASSAY Roche Diagnostics Corp. NBC Class II 2003-11-12
K033061 CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE Diamond Diagnostics, Inc. JIX Class II 2003-11-07
K032697 DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) Dade Behring, Inc. JIS Class II 2003-11-07
K033127 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS Ortho-Clinical Diagnostics JJX Class I 2003-10-31
K032993 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS Ortho-Clinical Diagnostics, Inc. JJX Class I 2003-10-31
K032798 DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A Dade Behring, Inc. JHM Class I 2003-10-30
K032002 FERTELL FEMALE FERTILITY TEST Genosis, Inc. NGA Class I 2003-10-30
K030394 FLUID SAMPLE RETRIEVAL SYSTEM Biomed Personal Metabolic and Nutritional Testing JKA Class II 2003-10-27
K023885 COMBI-SCREEN, MODELS 10SL AND 11SL Analyticon Biotechnologies AG JIL Class II 2003-10-21
K032074 LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS Cliniqa Corporation JJY Class I 2003-10-21
K032608 GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB JIS Class II 2003-10-21
K032985 GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM Hmd Biomedical, Inc. NBW Class II 2003-10-21
K032819 GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM Bionostics, Inc. JJX Class I 2003-10-20
K032939 EPT CERTAINTY PREGNANCY TEST Unipath , Ltd. LCX Class II 2003-10-20
K032311 ROCHE DIAGNOSTICS OMNI S ANALYZER Roche Diagnostics Corp. CEM Class II 2003-10-17
K033009 ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2 Roche Diagnostics Corp. CIX Class II 2003-10-16
K031501 EASYGLUCO, MODEL IGM0002 American Healthcare, Inc. NBW Class II 2003-10-16
K033185 COBAS INTEGRA ALP IFCC GEN.2 Roche Diagnostics Corp. CJE Class II 2003-10-14
K032661 ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE) ACON Laboratories, Inc. LCX Class II 2003-10-14
K032881 IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE Diagnostic Products Corp. CDZ Class I 2003-10-10
K033162 LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS Cliniqa Corporation JJY Class I 2003-10-10

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