meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
44
Latest Decision
2004-10-19

Clearances · page 26 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K040866 FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST Armkel, LLC LCX Class II 2004-10-19
K041975 VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501 Maine Standards Co. JJY Class I 2004-10-15
K041874 ABL800 FLEX Radiometer Medical Aps CHL Class II 2004-10-08
K042189 DIAZYME SODIUM ENZYMATIC ASSAY Diazyme Laboratories MZU Class II 2004-10-07
K042324 LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5 Bio-Rad JJY Class I 2004-10-07
K042270 STAT K IN VITRO DIAGNOSTIC TEST SYSTEM Stat Chem, Inc. CEM Class II 2004-10-06
K042651 FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS Beckman Coulter, Inc. JIT Class II 2004-10-05
K042243 MICROALBUMIN MULTI-CALIBRATOR SET Diagnostic Chemicals , Ltd. JIX Class II 2004-10-04
K042425 AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT Wallac OY JLX Class I 2004-09-30
K042490 ELECSYS FOLATE II CALSET II Roche Diagnostics Corp. JIT Class II 2004-09-30
K042424 DELFIA NEONATAL 17A-OH-PROGESTERONE KIT Wallac OY JLX Class I 2004-09-30
K041866 ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) Axis-Shield Diagnostics, Ltd. CDZ Class I 2004-09-29
K042015 ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE Bayer Healthcare, Diagnostics Division CGA Class II 2004-09-29
K041905 HEMOSIL CALIBRATION PLASMA Instrumentation Laboratory CO JIX Class II 2004-09-28
K042303 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS Ortho-Clinical Diagnostics JJX Class I 2004-09-27
K041349 LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM Ibl GmbH CHP Class I 2004-09-24
K042335 ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05 Bio-Rad Laboratories, Inc. JJY Class I 2004-09-17
K042195 SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747 Beckman Coulter, Inc. LBS Class I 2004-09-16
K042281 MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY Beckman Coulter, Inc. JLW Class II 2004-09-16
K042389 MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA Roche Diagnostics Corp. JJY Class I 2004-09-14
K041811 ABBOTT AXSYM TROPONIN-I ADV Abbott Laboratories MMI Class II 2004-09-10
K042280 FACT PLUS ONE-STEP PREGNANCY TEST KIT Unipath , Ltd. LCX Class II 2004-09-10
K042151 ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST ACON Laboratories, Inc. LCX Class II 2004-09-09
K041361 RANDOX TRI LEVEL CARDIAC CONTROL Randox Laboratories Limited JJY Class I 2004-09-09
K041627 CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR Dako A/S NDY Class II 2004-09-03
K041657 THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT Thermo Electron Corporation KQN Class II 2004-08-30
K042005 ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222 Taidoc Technology Corporation NBW Class II 2004-08-27
K041720 VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II Ortho-Clinical Diagnostics, Inc. MRR Class I 2004-08-25
DEN040002 NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970 Perkinelmer Life Sciences, Inc. NQL Class II 2004-08-24
K042080 TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM Home Diagnostics, Inc. JJX Class I 2004-08-19
K041687 ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR Abbott Laboratories JJX Class I 2004-08-18
K041643 SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT Beckman Coulter, Inc. CEO Class I 2004-08-18
K041194 ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H Medical Analysis Systems, Inc. JJX Class I 2004-08-16
K041898 CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM Cliniqa Corporation JJX Class I 2004-08-16
K041946 ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE ACON Laboratories, Inc. JHI Class II 2004-08-16
K041871 INTERLAB MICROCAL SERUM CONTROLS Trouble Shooter Consuling, Inc. JJX Class I 2004-08-16
K041878 N LATEX CYSTATIN Dade Behring, Inc. NDY Class II 2004-08-16
K041192 ARCHITECT STAT TROPONIN-I IMMUNOASSAY Fisher Diagnostics MMI Class II 2004-08-12
K041728 HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE Immunostics Inc., JHI Class II 2004-08-11
K040848 EZ SMART Vip International Wholesalers, Corp. NBW Class II 2004-08-11
K041748 AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM) Azog, Inc. LCX Class II 2004-08-09
K040107 CYTO-CHEX BCT Streck Laboratories, Inc. JKA Class II 2004-07-27
K041812 MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC) Roche Diagnostics Corp. JJY Class I 2004-07-27
K041870 N APOLIPOPROTEIN STANDARD SERUM Dade Behring, Inc. JIX Class II 2004-07-27
K041750 PTS PANELS CHOL+GLU TEST PANEL Polymer Technology Systems, Inc. NBW Class II 2004-07-23
K040923 LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA Ibl GmbH JLS Class I 2004-07-22
K041596 ARCHITECT STAT CK-MB IMMUNOASSAY Fisher Diagnostics JHX Class II 2004-07-21
K041417 DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423 Dade Behring, Inc. NBC Class II 2004-07-20
K041793 OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 Olympus America, Inc. JMO Class I 2004-07-16
K040678 EUSURE BLOOD GLUCOSE MONITORING SYSTEM Eumed Biotechnology Co., Ltd. NBW Class II 2004-07-14
K041014 TSH-CTK-3 IRMA DiaSorin, Inc. JLW Class II 2004-07-14
K040459 TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS Biosite Incorporated JJY Class I 2004-07-06
K040693 PTS PANELS LDL CHOLESTEROL TEST STRIPS Polymer Technology Systems, Inc. MRR Class I 2004-07-06
K041133 MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER Bayer Healthcare, LLC CDD Class II 2004-07-02
K041052 RAICHEM GLUCOSE UV (LIQUID) Hemagen Diagnostics, Inc. CFR Class II 2004-06-30
K041051 RAICHEM BUN RATE REAGENT (LIQUID) Hemagen Diagnostics, Inc. CDQ Class II 2004-06-30
K041009 RAICHEM CALCIUM (OCPC) LIQUID REAGENT Hemagen Diagnostics, Inc. CIC Class II 2004-06-25
K041107 TAIDOC CHECK Taidoc Technology Corporation NBW Class II 2004-06-18
K041165 FSH MENOPAUSE PREDICTOR TEST ACON Laboratories, Inc. CGJ Class I 2004-06-17
K040332 POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER Arkray, Inc. JJF Class I 2004-06-16
K040379 RANDOX IMMUNOASSAY CONTROL Randox Laboratories, Ltd. JJY Class I 2004-06-16
K040425 ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS Bayer Healthcare, LLC NBC Class II 2004-06-14
K040813 NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022 Nichols Institute Diagnostics CEW Class II 2004-06-08
K041404 CLEARBLUE EASY EASY READ PREGNANCY TEST Unipath , Ltd. LCX Class II 2004-06-08
K040767 SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT Beckman Coulter, Inc. LBS Class I 2004-06-07
K040391 TOTAL BILIRUBIN REAGENT SET Pointe Scientific, Inc., CIG Class II 2004-06-02
K041358 VENOJECT LUER ADAPTER Terumo Europe N.V. JKA Class II 2004-05-28
K041227 MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA Roche Diagnostics Corp. JJY Class I 2004-05-27
K033627 Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM Biomedix, Inc. CGA Class II 2004-05-21
K041073 DOCUMENT SALICYLATE CAL VER Microgenics Corp. JJY Class I 2004-05-21
K033983 VITALAB IRON REAGENT Clinical Data, Inc. JIY Class I 2004-05-21
K041230 CLINICAL LABORATORY ANALYZING SYSTEM Hemocue, Inc. LFR Class II 2004-05-20
K033899 LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR Lifestream Technologies, Inc. NFX Class I 2004-05-20
K040575 PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 Phamatech, Inc. CGJ Class I 2004-05-20
K041273 ONE-STEP PREGNANCY TEST W.H.P.M., Inc. LCX Class II 2004-05-20
K040822 LIQUICHEK TORCH PLUS IGM CONTROL Bio-Rad Laboratories, Inc. JJY Class I 2004-05-19
K040603 PARADIGM LINK BLOOD GLUCOSE METER Becton, Dickinson & CO NBW Class II 2004-05-19
K033688 MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY Micro Direct, Inc. NRH Class I 2004-05-19
K033747 RAMP CK-MB ASSAY Response Biomedical Corp. JHX Class II 2004-05-17
K040918 WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2 Wako Chemicals USA, Inc. JJX Class I 2004-05-17
K040927 LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS Cliniqa Corporation JJX Class I 2004-05-17
K033745 RAMP TROPONIN I ASSAY Response Biomedical Corp. MMI Class II 2004-05-17
K040733 ELECSYS TROPONIN T STAT TEST Roche Diagnostics Corp. MMI Class II 2004-05-17
K040174 BILIRUBIN ASSAY ON THE OMNI S ANALYZER Roche Diagnostics Corp. MQM Class I 2004-05-14
K041071 BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381 Becton, Dickinson & CO JKA Class II 2004-05-14
K040920 AMYLASE LIQUID REAGENT, MODEL A532-200 Teco Diagnostics JFJ Class II 2004-05-10
K041016 NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS Nova Biomedical Corp. JJX Class I 2004-05-07
K040761 AXSYM CYCLOSPORINE Abbott Laboratories, Inc. MKW Class II 2004-04-30
K040008 QUICKVUE ADVANCE PH AND AMINES GLL TEST Quidel Corp. CEN Class I 2004-04-29
K040925 NORMAL AND HYPERGAMMA CONTROL SERUM Sebia JJY Class I 2004-04-28
K040880 MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 Medical Analysis Systems, Inc. JJY Class I 2004-04-28
K033114 KETOCHECKS Neo Diagnostics, Inc. JIN Class I 2004-04-26
K033860 AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR Wako Chemicals USA, Inc. JIT Class II 2004-04-23
K040796 ACCU-CHEK GO SYSTEM Roche Diagnostics Corp. LFR Class II 2004-04-22
K033727 NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY Nichols Institute Diagnostics CEW Class II 2004-04-22
K040814 MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM Abbott Laboratories NBW Class II 2004-04-15
K040692 OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023 Olympus America, Inc. JIT Class II 2004-04-08
K040264 CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF Roche Diagnostics Corp. JIX Class II 2004-04-02
K040352 NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL) Bioresource Technology, Inc. JJY Class I 2004-04-02
K040535 LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS Cliniqa Corporation JJY Class I 2004-03-29

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