meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
47
Latest Decision
2005-05-13

Clearances · page 25 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K050961 RNA1C CONTROL FOR NYCOCARD HBA1C Bionostics, Inc. JJX Class I 2005-05-13
K050930 E.P.T. CERTAINTY PREGNANCY TEST Unipath , Ltd. LCX Class II 2005-05-12
K043218 ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX Radiometer Medical Aps CHL Class II 2005-05-10
K042421 URITEK 151 URINE ANALYZER, MODEL TC-151 Teco Diagnostics KQO Class I 2005-05-09
K043125 ORION DIAGNOSTICA UNIQ PINP RIA Orion Diagnostica, OY CIN Class II 2005-05-04
K050872 ACCU-CHEK INTEGRA SYSTEM Roche Diagnostics Corp. LFR Class II 2005-05-02
K043245 EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM Eps Bio Technology Corp. CGA Class II 2005-04-29
K050537 LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS Bio-Rad JJY Class I 2005-04-27
K042767 DATAPRO CLINICAL CHELISTRY ANALYZER Thermo Electron Corporation CFR Class II 2005-04-27
K043474 ACCU-CHEK AVIVA SYSTEM Roche Diagnostics Corp. LFR Class II 2005-04-27
K043231 PROOF POSITIVE ELECTRONIC PREGNANCY TEST Mizuho USA, Inc. LCX Class II 2005-04-25
K050387 ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR Roche Diagnostics Corp. JJY Class I 2005-04-25
K050423 OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE) Roche Diagnostics CHL Class II 2005-04-22
K043228 ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS Bayer Healthcare, LLC NBC Class II 2005-04-22
K043143 SAFEPICO Radiometer Medical Aps JKA Class II 2005-04-22
K050801 URISCAN OPTIMA II URINE ANALYZER Yd Diagnostics JIL Class II 2005-04-20
K042927 VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES Greiner Bio-One Vacuette North America PJE Class II 2005-04-15
K043385 OSOM HCG COMBO TEST Genzyme Diagnostics JHI Class II 2005-04-12
K043512 EASYGLUCO IGM-0002 G2 American Healthcare, Inc. CGA Class II 2005-04-08
K043543 BLOOD GLUCOSE MONITORING SYSTEM American Healthcare, Inc. NBW Class II 2005-04-08
K043443 ONE STEP HCG URINE PREGNANCY TEST Guangzhou Wondfo Biotech Co., Ltd. LCX Class II 2005-04-08
K050652 SPOTCHEM II CREATININE, AMYLASE & ALP TESTS Arkray, Inc. CGX Class II 2005-04-06
K050328 PREGNANCY-SKREEN Biochemical Diagnostic, Inc. JJX Class I 2005-03-29
K050504 VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS Maine Standards Co. JJY Class I 2005-03-25
K041881 ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100 Hypoguard USA, Inc. CGA Class II 2005-03-25
K050536 QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL Bio-Rad JJY Class I 2005-03-24
K050125 RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 More Diagnostics JJY Class I 2005-03-18
K050206 CEDIA TACROLIMUS ASSAY Microgenics Corp. MLM Class II 2005-03-15
K042169 STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER Stanbio Laboratory JJE Class I 2005-03-14
K042795 CLEVER CHEK TD-3213 Taidoc Technology Corporation NBW Class II 2005-03-07
K043599 MOMENTS MENOPAUSE CHECK, MODEL 9113 Phamatech, Inc. CGJ Class I 2005-02-25
K050100 RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER Bionostics, Inc. JJX Class I 2005-02-25
K050191 MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE Becton, Dickinson & CO PER Class I 2005-02-22
K050077 SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS Arkray, Inc. CIC Class II 2005-02-15
K043268 SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 Randox Laboratories, Ltd. CEI Class II 2005-02-15
K043476 STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT Dade Behring, Inc. NBC Class II 2005-02-15
K043266 RANDOX URINE CONTROLS Randox Laboratories, Ltd. JJW Class I 2005-02-15
K040958 PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 Tokyo Boeki Medical System , Ltd. JJE Class I 2005-02-15
K043267 POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 Randox Laboratories, Ltd. CEJ Class II 2005-02-10
K050202 CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS Beckman Coulter, Inc. CGR Class II 2005-02-09
K043584 LIQUICHEK BNP CONTROL Bio-Rad Laboratories, Inc. JJX Class I 2005-02-08
K050026 PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC Roche Diagnostics JIX Class II 2005-01-31
K043460 OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071 Olympus America, Inc. JIX Class II 2005-01-31
K043264 LDL-EX SEIKEN ASSAY KIT Denka Seiken Co., Ltd. MRR Class I 2005-01-26
K043546 DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE Dade Behring, Inc. CDT Class I 2005-01-18
K043208 LIQUID ASSAYED MULTIQUAL CONTROL Bio-Rad JJY Class I 2005-01-07
K042641 CHEMVIEW-10 Cenogenics Corp. JIL Class II 2005-01-07
K042678 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM Bionime Corporation NBW Class II 2005-01-03
K043378 DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT Drew Scientific , Ltd. JIT Class II 2004-12-29
K042362 MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12 Diagnostic Chemicals , Ltd. KHS Class II 2004-12-27
K040972 CALCIUM, AZO DYE REAGENT Genchem, Inc. CJY Class II 2004-12-27
K040977 GENCHEM ELECTROLYTE BUFFER Genchem, Inc. JGS Class II 2004-12-27
K040976 GENCHEM CREATININE REAGENT Genchem, Inc. CGX Class II 2004-12-27
K040973 BUN REAGENT Genchem, Inc. CDS Class II 2004-12-27
K040975 GENCHEM CO2 ACID REAGENT Genchem, Inc. JFL Class II 2004-12-27
K040974 GLUCOSE OXIDASE, GLUCOSE Genchem, Inc. CGA Class II 2004-12-27
DEN040012 AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM Affymetrix, Inc. NSU Class II 2004-12-23
K043318 MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY Roche Diagnostics Corp. CGN Class II 2004-12-23
K043202 OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 Olympus America, Inc. CGS Class II 2004-12-23
K043311 ASCENSIA ELITE DIABETES CARE SYSTEM Bayer Healthcare, LLC NBW Class II 2004-12-22
K043158 ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM Bayer Healthcare, LLC NBW Class II 2004-12-22
K040971 GENCHEM ISE ELECTROLYTE REFERENCE Genchem, Inc. JGS Class II 2004-12-22
K041619 BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 Biocheck, Inc. MMI Class II 2004-12-17
K043320 MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II Roche Diagnostics Corp. JJX Class I 2004-12-17
K042676 NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY Nichols Institute Diagnostics DHA Class II 2004-12-17
K042838 VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II Ortho-Clinical Diagnostics, Inc. JIT Class II 2004-12-09
K042689 NICHOLS ADVANTAGE CORTISOL Nichols Institute Diagnostics CGR Class II 2004-12-09
K043070 LIQUID STABLE HBA1C CONTROL Canterbury Scientific , Ltd. JJX Class I 2004-12-09
K042318 AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET Aalto Scientific, Ltd. JJY Class I 2004-12-09
K043108 LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL Bio-Rad Laboratories, Inc. JJY Class I 2004-12-07
K042406 OLYMPUS LACTATE, OSR6193 Olympus America, Inc. JIT Class II 2004-12-03
K042519 GAMMA-B 1,25-DIHYDROXY VITAMIN D Immunodiagnostic Systems , Ltd. MRG Class II 2004-12-01
K042443 SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL Arkray, Inc. CHH Class I 2004-11-24
K043175 ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE Roche Diagnostics Corp. NHG Class II 2004-11-24
K041427 THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS Arkray, Inc. CGA Class II 2004-11-24
K041927 LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 Diagnostic Chemicals , Ltd. MRR Class I 2004-11-23
K041928 HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B Diagnostic Chemicals , Ltd. LBS Class I 2004-11-23
K041926 HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 Diagnostic Chemicals , Ltd. JIX Class II 2004-11-23
K043095 ROCHE DIAGNOSTICS ELECSYS AFP CALSET II Roche Diagnostics Corp. JIT Class II 2004-11-23
K042227 INSTANT-VIEW TROPONIN I TEST Alfa Scientific Designs, Inc. MMI Class II 2004-11-19
K042473 COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM Cobe Cardiovascular, Inc. JQC Class I 2004-11-19
K042347 MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD Dade Behring, Inc. NBC Class II 2004-11-19
K042625 QUIKREAD CRP CALIBRATOR SET Orion Diagnostica, OY JJY Class I 2004-11-18
K042521 VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS Ortho-Clinical Diagnostics, Inc. JIT Class II 2004-11-18
K042551 MULTI-CHEM CALIBRATOR A Wako Chemicals USA, Inc. JIX Class II 2004-11-16
K042291 UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS Beckman Coulter, Inc. CEM Class II 2004-11-12
K042550 MULTI-LIPID CALIBRATOR Wako Chemicals USA, Inc. JIX Class II 2004-11-08
K042549 MULTI CHEM CAL B Wako Chemicals USA, Inc. JIX Class II 2004-11-08
K042717 MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL Medical Analysis Systems, Inc. JJX Class I 2004-11-05
K042815 QUEST TUMOR MARKER CONTROL, MODEL 955 Bio-Rad JJY Class I 2004-11-05
K042307 ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) Seradyn, Inc. JIT Class II 2004-11-03
K042446 QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS Bio-Rad Laboratories, Inc. JJW Class I 2004-11-02
K042837 LIQUICHEK ELEVATED CRP CONTROL Bio-Rad JJX Class I 2004-11-02
K042191 DIAZYME POTASSIUM ENZYMATIC ASSAY KIT Diazyme Laboratories MZV Class II 2004-10-29
K041090 HDL-EX SEIKEN ASSAY KIT Denka Seiken Co., Ltd. LBS Class I 2004-10-29
K042448 DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT General Atomics JJX Class I 2004-10-29
K042006 VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE Ortho-Clinical Diagnostics, Inc. LBS Class I 2004-10-28
K041478 BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR Becton Dickinson CGA Class II 2004-10-28
K040750 BIO-CHEM ANALYZER, MODEL 100 Clinical Analysis Corporation, Inc. CEM Class II 2004-10-28
K042183 GLUCOSE TOLERANCE BEVERAGE Ever Scientific MRV Class II 2004-10-27

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