meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
50
Latest Decision
2002-10-16

Clearances · page 30 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K023065 CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE Dade Behring, Inc. MKW Class II 2002-10-16
K022545 GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020 Hypoguard USA, Inc. NBW Class II 2002-10-11
K022757 SPIFE CK KIT, MODEL 3332, 3333 Helena Laboratories JHY Class II 2002-10-11
K022472 PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84) Nichols Institute Diagnostics CEW Class II 2002-10-09
K022580 BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM Becton, Dickinson & CO CGA Class II 2002-10-09
K022581 BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM Becton, Dickinson & CO NBW Class II 2002-10-09
K022946 LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST Princeton BioMeditech Corp. MMI Class II 2002-10-08
K023049 SYNCHRON LX I 725 CLINICAL SYSTEM Beckman Coulter, Inc. JGS Class II 2002-10-04
K022885 LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE Cliniqa Corporation JJY Class I 2002-10-02
K022936 LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE Cliniqa Corporation JJY Class I 2002-10-02
K022867 LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER IMMAGE Cliniqa Corporation JJY Class I 2002-10-02
K022455 SPIFE LD-12 KIT, MODEL 3338 Helena Laboratories CFE Class II 2002-10-01
K022409 SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST Spectral Diagnostics, Inc. JHT Class II 2002-09-30
K022519 LDL CHOLESTEROL (AUTOMATED) Jas Diagnostics, Inc. JHM Class I 2002-09-30
K022533 FASTPACK TESTOSTERONE CALIBRATOR Qualigen, Inc. JIT Class II 2002-09-30
K021814 ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345 Beckman Coulter, Inc. MMI Class II 2002-09-27
K022851 PH AND AMINES EXTERNAL CONTROL SET Quidel Corp. JJY Class I 2002-09-27
K022901 VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS Ortho-Clinical Diagnostics JIS Class II 2002-09-27
K022898 PTS PANELS LIPID PANEL TEST STRIPS Polymer Technology Systems, Inc. CHH Class I 2002-09-24
K020808 FERTILITE OV Pheromone Sciences Corp. NGE Class I 2002-09-23
K022725 CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013 Good Biotech Corp. JJX Class I 2002-09-23
K021698 MY ALLERGY TEST Immunetech Corporation JKA Class II 2002-09-19
K022386 POCKETCHEM UA AUTION STICKS 10TA Arkray, Inc. JIL Class II 2002-09-17
K022772 RAICHEM LDL-CHOLESTEROL DIRECT REAGENT Hemagen Diagnostics, Inc. MRR Class I 2002-09-17
K022758 LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER Cliniqa Corporation JJX Class I 2002-09-17
K022991 LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596 Bio-Rad JJY Class I 2002-09-17
K022339 TOTAL BILIRUBIN Abbott Laboratories CIG Class II 2002-09-13
K022724 SURESTEP BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. NBW Class II 2002-09-12
K022875 MODIFICATION TO BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET Becton, Dickinson & CO JKA Class II 2002-09-11
K022158 IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT) Instrumentation Laboratory CO CGA Class II 2002-09-10
K021334 WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5 Wiener Laboratories Saic CJY Class II 2002-09-10
K021218 ELECSYS CORTISOL TEST SYSTEM Roche Diagnostics Corp. JFT Class II 2002-09-09
K022182 MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM Abbott Laboratories NBW Class II 2002-09-09
K022180 DIRECT BILIRUBIN Abbott Laboratories CIG Class II 2002-09-06
K022312 PICCOLO PHOSPHORUS TEST SYSTEM Abaxis, Inc. CEO Class I 2002-09-05
K022767 RAICHEM LIPID CALIBRATOR Hemagen Diagnostics, Inc. JIX Class II 2002-09-03
K021781 EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS Chay Medical, LLC CGA Class II 2002-08-30
K022591 RANDOX LIPID CONTROL Randox Laboratories, Ltd. JJY Class I 2002-08-30
K022654 MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB Roche Diagnostics Corp. JHY Class II 2002-08-29
K022491 LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS Cliniqa Corporation JJX Class I 2002-08-27
K022072 PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS Precision Systems, Inc. CIX Class II 2002-08-23
K022538 IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 Diagnostic Chemicals, Ltd. (Usa) JIR Class I 2002-08-23
K021819 ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. NBW Class II 2002-08-23
K022401 PTS PANELS MULTI-CHEMISTRY CONTROLS Polymer Technology Systems, Inc. JJY Class I 2002-08-21
K022603 IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER Diagnostic Products Corp. CEW Class II 2002-08-21
K021972 FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY Qualigen, Inc. CDZ Class I 2002-08-21
K021960 PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY Abbott Laboratories LFR Class II 2002-08-16
K022525 LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509 Bio-Rad JJS Class I 2002-08-15
K022529 LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669 Bio-Rad JJS Class I 2002-08-15
K022333 SPIFE LIPPOROTEIN-12, MODEL 3344 Helena Laboratories JHO Class I 2002-08-15
K021902 MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300 Medtronic Vascular JQC Class I 2002-08-12
K022426 BD PRESET BLOOD COLLECTION SYRINGE, BD A-LINE BLOOD COLLECTION SYRINGE, MODELS 365313, 365323,365316,365356,365373,36538 Becton, Dickinson & CO JKA Class II 2002-08-08
K021386 POLY STAT HCG DIPSTICK TEST Alidex, Inc. JHI Class II 2002-08-05
K022232 CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3 Cliniqa Corporation JJX Class I 2002-08-01
K022130 BD VACUTAINER PLUS PST II TUBE Becton, Dickinson & CO JKA Class II 2002-07-29
K022085 J&S MEDICAL SENTRY URINE DIPSTICK CONTROL J & S Medical Assoc., Inc. JJW Class I 2002-07-25
K022108 THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050 Thermo Dma, Inc. JIX Class II 2002-07-25
K021713 STAT PROFILE PHOX PLUS C ANALYZER Nova Biomedical Corp. CHL Class II 2002-07-25
K021316 ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR Genzyme Corp. LBS Class I 2002-07-25
K022171 ACCU-CHEK COMPACT SYSTEM Roche Diagnostics Corp. NBW Class II 2002-07-23
K022118 IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) Diagnostic Products Corp. JHX Class II 2002-07-22
K022027 CALIBRATING MATERIAL, BUFFERS, STANDARD Mission Diagnostics JIT Class II 2002-07-22
K021671 JAS HDL CHOLESTEROL (AUTOMATED) REAGENT Jas Diagnostics, Inc. LBS Class I 2002-07-19
K013420 CHEMWELL, ALSO KNOWN AS PROJECT 2900 Awareness Technology, Inc. JLW Class II 2002-07-19
K022049 MODIFICATION TO RAICHEM CALCIUM REAGENT Hemagen Diagnostics, Inc. CJY Class II 2002-07-19
K021326 VIDAS TESTOSTERONE (TES), MODEL 30 418 bioMerieux, Inc. CDZ Class I 2002-07-18
K021636 ALBUMIN REAGENT Intersect Systems, Inc. CJW Class II 2002-07-17
K022041 LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 Bio-Rad Laboratories, Inc. JJY Class I 2002-07-16
K021515 EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER Medica Corp. CHL Class II 2002-07-16
K020968 LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD Pan Probe Biotech, Inc. JHI Class II 2002-07-15
K021151 AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM Bayer Diagnostics Corp. JIF Class I 2002-07-13
K022053 HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134 Sebia JHO Class I 2002-07-12
K021624 RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4 Bionostics, Inc. JJX Class I 2002-07-12
K021927 PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM Biomet, Inc. LXG Class I 2002-07-12
K021385 ATAC PAK BUN REAGENT Elan Diagnostics CDQ Class II 2002-07-12
K021697 GLUCOSE CONTROL SOLUTION FOR BD LATITUDE Bionostics, Inc. JJX Class I 2002-07-12
K021428 CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM Bayer Corp. JFY Class II 2002-07-05
K020852 POLY-CHEM GLUCOSE Polymedco, Inc. CFR Class II 2002-07-03
K021827 MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM Roche Diagnostics Corp. NBW Class II 2002-07-03
K021332 WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA Wiener Laboratories Saic CGS Class II 2002-07-03
K020484 CARESIDE LDH Careside, Inc. CFH Class II 2002-07-03
K021941 SAMPLOK LUER KIT Itl Corporation Pty, Ltd. JKA Class II 2002-07-02
K021317 TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST Biosite Incorporated NBC Class II 2002-07-01
K020486 CARESIDE GGT Careside, Inc. JPZ Class I 2002-07-01
K021943 ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. CGA Class II 2002-06-28
K021607 RDI HS CRP CALIBRATOR SET Reference Diagnostics, Inc. JIT Class II 2002-06-27
K021535 ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR Bayer Diagnostics Corp. JIT Class II 2002-06-27
K021532 ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR Bayer Diagnostics Corp. JIT Class II 2002-06-27
K021930 MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL Bionostics, Inc. JJY Class I 2002-06-25
K014018 CHOLESTEROL 1, 2, 3 Imi LBS Class I 2002-06-24
K020980 DIMENSION TPSA CALIBRATOR, MODEL #RC459 Dade Behring, Inc. JIT Class II 2002-06-21
K020378 QUPID PLUS E.R. Stanbio Laboratory JHI Class II 2002-06-21
K020866 FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM Abbott Diabetes Care, Inc. NBW Class II 2002-06-11
K021513 ACCU-CHEK ADVANTAGE MODULE Roche Diagnostics Corp. NBW Class II 2002-06-11
K021381 MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2 Dade Behring, Inc. JJY Class I 2002-06-10
K020297 STAT PROFILE CRITICAL CARE XPRESS ANALYZER Nova Biomedical Corp. CHL Class II 2002-06-10
K013654 PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER Precision Systems, Inc. JJF Class I 2002-06-05
K020487 CARESIDE ALT Careside, Inc. CKA Class I 2002-06-04
K020364 PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS Phoenix Diagnostics, Inc. JGS Class II 2002-06-04
K021032 ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 Scantibodies Laboratory, Inc. CKG Class II 2002-06-03

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