meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
43
Latest Decision
2003-10-08

Clearances · page 28 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K032437 CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS Roche Diagnostics Corp. JIL Class II 2003-10-08
K031873 I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET I-Stat Corporation JJX Class I 2003-10-07
K032458 ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT Abbott Laboratories JIT Class II 2003-10-06
K032161 PHEM-ALERT Femtek,Llc. LNW Class I 2003-09-30
K032076 SENOVA(R) BLOOD GLUCOSE MONITOR Chdiagnostics, LLC LFR Class II 2003-09-30
K030003 ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR Elan Diagnostics CIG Class II 2003-09-29
K031031 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS Ortho-Clinical Diagnostics, Inc. MMI Class II 2003-09-29
K030014 ATAC TOTAL BILIRUBIN REAGENT Elan Diagnostics CIG Class II 2003-09-26
K032510 ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST ACON Laboratories, Inc. LCX Class II 2003-09-22
K030815 AKERS LABORATORIES INC. BLOOD CELL SEPARATOR Akers Laboratories, Inc. JKA Class II 2003-09-17
K031359 S-MONOVETTE EDTA K2-GEL Sarstedt, Inc. PJE Class II 2003-09-12
K032552 ACCU-CHEK ADVANTAGE SYSTEM Roche Diagnostics Corp. NBW Class II 2003-09-12
K032525 BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER Bayer Healthcare, LLC NBC Class II 2003-09-09
K032122 AUDIT MICROCONTROLS MICROFD BNP CONTROL Aalto Scientific, Ltd. JJY Class I 2003-09-09
K032027 CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) Cholestech Corp. CIS Class II 2003-09-05
K032159 CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY Access Bio Incorporate LCX Class II 2003-09-05
K032237 N/T PROTEIN CONTROL Dade Behring, Inc. JJY Class I 2003-09-05
K032012 HOMOCYSTEINE MICROTITER PLATE ASSAY Diazyme Laboratories LPS Class II 2003-09-03
K031739 I-STAT CARDIAC TROPONIN (CTNI) TEST I-Stat Corporation MMI Class II 2003-09-02
K032453 ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL Bionostics, Inc. JJY Class I 2003-08-28
K031921 LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS Cliniqa Corporation JJY Class I 2003-08-25
K030860 ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 Monobind KLI Class II 2003-08-22
K032285 OLYMPUS PREALBUMIN CALIBRATOR, ODR3029 Olympus America, Inc. JIT Class II 2003-08-21
K032377 ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID Roche Diagnostics Corp. KHS Class II 2003-08-21
K031990 ELECSYS PRECICONTROL TROPONIN T Roche Diagnostics Corp. JJX Class I 2003-08-20
K031698 ELECYS SHBG CALCHECK Roche Diagnostics Corp. JJX Class I 2003-08-20
K032335 MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL Medical Analysis Systems, Inc. JJY Class I 2003-08-19
K030730 FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT Diagnostics Biochem Canada, Inc. CDZ Class I 2003-08-18
K032287 MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 Beckman Coulter, Inc. JIX Class II 2003-08-18
K013643 AUSAM TOTAL ALBUMIN ASSAY Ausam Biotecthnologies, Inc. JIQ Class I 2003-08-14
K032296 VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS Ortho-Clinical Diagnostics, Inc. JIS Class II 2003-08-13
K031608 RANDOX LIQUID PROTEIN CALIBRATOR Randox Laboratories, Ltd. JIX Class II 2003-08-08
K030596 IMMUNICON CELLSAVE PRESERVATIVE TUBE Immunicon Corp. JKA Class II 2003-08-08
K031924 VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1 Ortho-Clinical Diagnostics JIT Class II 2003-08-07
K031577 LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS Cliniqa Corporation JJY Class I 2003-08-06
K031683 TOX AMMONIA CALIBRATOR Bayer Healthcare, LLC JIX Class II 2003-08-06
K031717 ELECSYS SHBG IMMUNOASSAY Roche Diagnostics Corp. CDZ Class I 2003-08-05
K031472 ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS Lifescan, Inc. CGA Class II 2003-08-05
K023279 GLUCOLEADER VALUE Hmd Biomedical, Inc. NBW Class II 2003-08-04
K032188 NICHOLS ADVANTAGE ALDOSTERONE ASSAY Nichols Institute Diagnostics CJM Class II 2003-07-31
K032089 ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC Roche Diagnostics Corp. JJY Class I 2003-07-30
K031534 CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001 Scantibodies Laboratory, Inc. CEW Class II 2003-07-30
K030058 EARLYDETECT MENOPAUSE TEST FOR FSH Early Detect, Inc. CGJ Class I 2003-07-30
K030912 THYRO TEST Thryotec JLW Class II 2003-07-25
K031575 LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS Cliniqa Corporation JJY Class I 2003-07-23
K031879 COBAS INTEGRA CARBON DIOXIDE ASSAY Roche Diagnostics Corp. KHS Class II 2003-07-17
K031890 MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL Medical Analysis Systems, Inc. JJX Class I 2003-07-16
K031880 AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL Roche Diagnostics Corp. JIX Class II 2003-07-16
K031044 ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR Clinical Data, Inc. KNK Class I 2003-07-15
K030600 AUTION JET AJ-4270 URINE ANALYZER International Remote Imaging Systems KQO Class I 2003-07-11
K030703 TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS Home Diagnostics, Inc. NBW Class II 2003-07-11
K030754 A/C ENZYMATIC HOMOCYSTEINE ASSAY Anticancer, Inc. LPS Class II 2003-07-11
K031824 COBAS INTEGRA CHOLESTEROL GEN. 2 Roche Diagnostics Corp. CHH Class I 2003-07-09
K030076 PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM Biomed Personal Metabolic and Nutritional Testing JKA Class II 2003-07-07
K030329 FASTPACK FREE T4 IMMUNOASSAY Qualigen, Inc. CEC Class II 2003-07-03
K031755 ACCU-CHEK COMPACT TEST STRIP Roche Diagnostics Corp. LFR Class II 2003-07-03
K031843 MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM Medline Industries, Inc. NBW Class II 2003-07-03
K024080 SECQUIRE CELL SEPARATOR Perfusion Partners & Assoc., Inc. JQC Class I 2003-07-02
K031445 MAINLINE MAXIE HCG URINE PREGNANCY TEST Mainline Technology, Inc. JHI Class II 2003-07-01
K031441 URICHEMTRAK LIQUID ASSAYED URINE CONTROL Medical Analysis Systems, Inc. JJW Class I 2003-07-01
K031756 ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY Roche Diagnostics Corp. CGN Class II 2003-06-25
K030035 IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE Diametrics Medical, Inc. JFY Class II 2003-06-25
K031682 LIPOPROTEIN CALIBRATOR Bayer Healthcare, LLC JIX Class II 2003-06-25
K031644 BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL Bayer Healthcare, LLC JJY Class I 2003-06-25
K031159 CALIBRATING MATERIAL, CALIBRATING STANDARDS Diamond Diagnostics, Inc. JIT Class II 2003-06-25
K023955 BD VIPER INSTRUMENT Becton, Dickinson & CO JQW Class I 2003-06-24
K031038 ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY Bayer Healthcare, LLC NBC Class II 2003-06-23
K031231 LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS Bio-Rad JJW Class I 2003-06-18
K030528 ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) Clinical Data JIY Class I 2003-06-17
K031271 ONE-STEP PREGNANCY TEST Amerisource Pharmacal, Inc. LCX Class II 2003-06-17
K031048 CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST Access Bio Incorporate JHI Class II 2003-06-16
K031101 RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 Hemagen Diagnostics, Inc. JJY Class I 2003-06-16
K030950 VIDAS TROPONIN I (TNI), MODEL 30 445 bioMerieux, Inc. MMI Class II 2003-06-16
K031052 CARESTART HCG ONE-STEP PREGNANCY TEST Access Bio Incorporate DHA Class II 2003-06-13
K031348 HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY Salimetrics, LLC NHG Class II 2003-06-10
K030964 CALIBRATION PLASMA LMW HEPARIN Instrumentation Laboratory CO JIS Class II 2003-06-06
K031135 GLUCOSE FLEX REAGENT CARTRIDGE (GLUC) Dade Behring, Inc. CFR Class II 2003-06-02
K030546 CRP (II) CALIBRATORS Denka Seiken Co., Ltd. JIS Class II 2003-06-02
K031364 MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 Medical Analysis Systems, Inc. JJY Class I 2003-05-30
K023823 EASYCUP Zer Hitech JHI Class II 2003-05-22
K031388 MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM Hypoguard USA, Inc. CGA Class II 2003-05-22
K031299 ELECSYS LH CALSET II Roche Diagnostics Corp. JIT Class II 2003-05-12
K030873 RANDOX AMMONIA Randox Laboratories, Ltd. JIF Class I 2003-05-12
K030573 BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341 Bd Vacutainer Systems Preanalyical Solutions JKA Class II 2003-05-08
K030659 CLEARBLUE EASY DIGITAL PREGNANCY TEST Unipath , Ltd. LCX Class II 2003-05-02
K030942 MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL Medical Analysis Systems, Inc. JJY Class I 2003-04-28
K023256 PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO Abbott Laboratories NBW Class II 2003-04-23
K030430 POLY STAT SERUM/URINE HCG TEST Alidex, Inc. JHI Class II 2003-04-18
K030533 ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST Cenogenics Corp. LCX Class II 2003-04-17
K030650 STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS Uridynamics, Inc. CEN Class I 2003-04-14
K030772 RDI EXTENDED RANGE CRP CALIBRATOR SET Reference Diagnostics, Inc. JIT Class II 2003-04-11
K030320 WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET Wako Chemicals USA, Inc. JIS Class II 2003-04-11
K030340 AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) Cytomedix JQC Class I 2003-04-11
K030555 GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A Biomet, Inc. JQC Class I 2003-04-11
K030804 BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR Bayer Healthcare, LLC JIX Class II 2003-04-10
K023037 MID STREAM PREGNANCY TEST Advanced Diagnostics, Inc. LCX Class II 2003-04-09
K030801 BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL Bayer Healthcare, LLC JJY Class I 2003-04-09
K021622 HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 Hill-Rom Air-Shields MQM Class I 2003-04-01
K023505 VBL SERUM TROPONIN I TEST, MODEL 1001 Vancouver Biotech , Ltd. MMI Class II 2003-03-31
K024347 EXPRESS BLOOD GLUCOSE MONITORING SYSTEM Hypoguard USA, Inc. CGA Class II 2003-03-28

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