meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
56
Latest Decision
1988-01-21

Clearances · page 80 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K874577 KODAK EKTACHEM DT SLIDES (PHOS) Eastman Kodak Company CEO Class I 1988-01-21
K875069 BILIRUBIN (TOTAL) Tech-Co, Inc. CIG Class II 1988-01-11
K875070 ALBUMIN, BROMCRESOL GREEN DYE-BINDING Tech-Co, Inc. CIX Class II 1988-01-11
K874624 FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301 Cyberfluor, Inc. CEP Class I 1988-01-11
K874621 FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201 Cyberfluor, Inc. CFT Class I 1988-01-11
K874820 MULTICHEM HDL PRECIPITATING REAGENT #S0914 Simmler, Inc. LBR Class I 1988-01-07
K874809 REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM Biotrol, USA, Inc. JJY Class I 1988-01-07
K874413 REAGENT A AND REAGENT B Seradyn, Inc. JIX Class II 1988-01-05
K874810 REFERENCE ASSAYED CHEMISTRY CONTROL SERUM Biotrol, USA, Inc. JJY Class I 1988-01-05
K874033 IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X Diagnostic Products Corp. JHI Class II 1988-01-05
K874704 REFLOTRON (R) AMYLASE Boehringer Mannheim Corp. JFJ Class II 1988-01-05
K874587 PARAMAX URINE/CSF CALIBRATOR Baxter Healthcare Corp JIX Class II 1988-01-05
K874941 BIOTROL BICARBONATE (CO2) UV HP) Biotrol, USA, Inc. KHS Class II 1988-01-05
K873893 LUMICON Hamilton Co. JJQ Class I 1988-01-05
K873371 URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC) Bio-Rad CHQ Class I 1988-01-05
K874532 BLOOD UREA NITROGEN Catachem, Inc. CDW Class II 1988-01-05
K874772 DC-TROL LEVEL 1 OR 2 Diagnostic Chemicals, Ltd. (Usa) JJY Class I 1988-01-05
K874032 IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5 Diagnostic Products Corp. CEP Class I 1987-12-30
K874459 LIQUI-SERA SPINAL FLUID CONTROL Biodiagnostic Intl JJY Class I 1987-12-29
K871835 GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT Miles Laboratories, Inc. CGA Class II 1987-12-22
K873372 HVA & HOMOVANILLIC ACID BY HPLC METHOD Bio-Rad CDF Class I 1987-12-22
K874472 INORGANIC PHOSPHORUS Catachem, Inc. CEO Class I 1987-12-22
K874640 WAKO(TM) AUTOKIT LIPASE Wako Chemicals USA, Inc. CHI Class I 1987-12-22
K874812 MULTICHEM CHLORIDE REAGENT S0933 Simmler, Inc. CHJ Class II 1987-12-18
K874545 IMACK-MB TEST PROCEDURE (MODIFICATION) Intl. Immunoassay Laboratories, Inc. JHY Class II 1987-12-18
K874708 EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008 Em Diagnostic Systems, Inc. LFR Class II 1987-12-18
K874603 CIBA CORNING T4 LIPIA (LIPOSOME IMMUNOASSAY) Ciba Corning Diagnostics Corp. KLI Class II 1987-12-18
K874847 MAGNESIUM Tech-Co, Inc. JGJ Class I 1987-12-18
K874622 FIAGEN(TM) HTSH CATALOGUE NUMBER: 101-301 Cyberfluor, Inc. JLW Class II 1987-12-18
K874848 LACTATE DEHYDROGENASE LDH-L Tech-Co, Inc. CFJ Class II 1987-12-18
K874658 TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C) Technicon Instruments Corp. CEE Class II 1987-12-18
K873519 PARAMAX CALCIUM REAGENT Baxter Healthcare Corp CIC Class II 1987-12-14
K873656 MEDATRON CUVETTE DISC Medatron, Inc. JRI Class I 1987-12-14
K873743 PARAMAX ISE CHLORIDE CALIBRATOR Baxter Healthcare Corp JIT Class II 1987-12-14
K873530 PARAMAX MAGNESIUM REAGENT Baxter Healthcare Corp JGJ Class I 1987-12-14
K874408 MULTI-FUNCTION BLOOD GAS CONTROL Bionostics, Inc. JJS Class I 1987-12-14
K874131 CRESOLPHTHALEIN COMPLEXONE, CALCIUM Pointe Scientific, Inc., CIC Class II 1987-12-04
K873903 ABBOTT PAP-EIA Abbott Laboratories JFH Class II 1987-12-01
K874262 LAD MODEL 735 LUMINOMETER Los Alamos Diagnostics JJQ Class I 1987-11-27
K874261 IQ/QCA TOTAL BILIRUBIN Bd Becton Dickinson Vacutainer Systems Preanalytic CIG Class II 1987-11-25
K874476 EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011 Em Diagnostic Systems, Inc. CEK Class II 1987-11-25
K874311 MULTICHEM (R) TOTAL BILIRUBIN Simmler, Inc. CIG Class II 1987-11-25
K870584 O.P.T.(TM) OVULATION PREDICTION TEST Warner-Lambert Co. CEP Class I 1987-11-25
K874145 TITAN GEL REP LDH-6 HV Helena Laboratories CFE Class II 1987-11-24
K874397 EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683 Em Diagnostic Systems, Inc. LBS Class I 1987-11-24
K873835 GLUCOSE-HK REAGENT Intersect Systems, Inc. CFR Class II 1987-11-24
K874142 TITAN GEL REP LDH-30 HV Helena Laboratories CFE Class II 1987-11-24
K873737 NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY Cambridge Medical Technology CDP Class II 1987-11-24
K874144 TITAN GEL REP CPK-6 HV Helena Laboratories JHX Class II 1987-11-23
K873945 CIBA CORNING MAGIC LITE T3 IMMUNOASSAY Ciba Corning Diagnostics Corp. CDP Class II 1987-11-23
K873534 OVUGEN SURETEST Biogenex Laboratories CEP Class I 1987-11-23
K873532 PARAMAX UREA NITROGEN REAGENT Baxter Healthcare Corp CDQ Class II 1987-11-23
K874477 EASY-TEST UREA NITROGEN (BUN) ITEM NUMBER: 19010 Em Diagnostic Systems, Inc. CDQ Class II 1987-11-23
K871755 PROTEIN STANDARD CALIBRATOR Wako Chemicals USA, Inc. JIX Class II 1987-11-23
K873520 PARAMAX AMYLASE REAGENT Baxter Healthcare Corp CJA Class II 1987-11-23
K873456 PARAMAX URIC ACID REAGENT Baxter Healthcare Corp KNK Class I 1987-11-23
K874258 VENTRESCREEN, HCG URINE Ventrex Laboratories, Inc. JHI Class II 1987-11-23
K874263 WAKO(TM) FE C Wako Chemicals USA, Inc. JIY Class I 1987-11-23
K873531 PARAMAX CREATININE REAGENT Baxter Healthcare Corp CGX Class II 1987-11-23
K874143 TITAN GEL REP LDH-12 HV Helena Laboratories CFE Class II 1987-11-23
K874163 ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS Catachem, Inc. CIX Class II 1987-11-23
K872818 REFLOTRON BILIRUBIN Boehringer Mannheim Corp. CIG Class II 1987-11-23
K874299 N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA) Incstar Corp. CEW Class II 1987-11-23
K873944 A-GENT LIQUID AMYLASE Abbott Laboratories JFJ Class II 1987-11-23
K873788 CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504 Pacific Biotech, Inc. JHI Class II 1987-11-23
K874230 PRECINORM L Boehringer Mannheim Corp. JJY Class I 1987-11-23
K873454 PARAMAX PHOSPHORUS REAGENT Baxter Healthcare Corp CEO Class I 1987-11-23
K874435 BICARBONATE Boehringer Mannheim Corp. KHS Class II 1987-11-23
K873936 MODIFIED PARAMAX GLUCOSE REAGENT Baxter Healthcare Corp CFR Class II 1987-11-23
K873932 THE EXTRACTOR(TM) Molecular Biosystems, Inc. DKO Class I 1987-11-20
K873384 CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA Helena Laboratories JJQ Class I 1987-11-20
K874088 EASY-TEST CREATININE (CREA) ITEM NO. 19009 Em Diagnostic Systems, Inc. CGX Class II 1987-11-06
K874146 TITAN GEL REP CPK-12 HV Helena Laboratories CGS Class II 1987-11-05
K873201 WAKO(TM) AUTOKIT CK-NAC Wako Chemicals USA, Inc. CGS Class II 1987-11-05
K873976 AMERLITE TT4 ASSAY (240/480/144 TEST KITS) Amersham Corp. KLI Class II 1987-11-05
K874248 SYNTRON BIORESEARCH U-TEST PREGNANCY TEST Syntron Bioresearch, Inc. LCX Class II 1987-11-04
K874141 TITAN GEL REP CPK/LDH ISOENZYME CONTROL Helena Laboratories JJT Class I 1987-11-04
K874094 1205 BETAPLATE LIQUID SCINTILLATION COUNTER Lkb Instruments, Inc. JJJ Class I 1987-11-04
K874185 DART (R) ELECTROLYTE REAGENT SYSTEM Coulter Electronics, Inc. JGS Class II 1987-11-04
K873451 PROJECT 300 MICROASSAY BP-12, EIA MINILAB Awareness Technology, Inc. JJQ Class I 1987-11-04
K874153 EASY-TEST PHOSPHORUS (PHOS) ITEM NO. 16687 Em Diagnostic Systems, Inc. CEO Class I 1987-11-04
K874140 TITAN GEL REP SIMULTANEOUS CK-LD ISOENZYME PROCED. Helena Laboratories CGS Class II 1987-11-03
K873858 AMERLITE TT3 ASSAY, LAN.0003/1003/2003 Amersham Corp. CDP Class II 1987-11-03
K874061 TSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1093 Medix Biotech, Inc. JLW Class II 1987-11-03
K874244 DYNATECH MR 300 MANUAL MICROELISA Dynatech Laboratories, Inc. JJQ Class I 1987-11-03
K874139 TITAN GEL REP CPK-30 HV Helena Laboratories CGS Class II 1987-11-03
K874049 MULTICHEM ALBUMIN REAGENT S0902 Simmler, Inc. CIX Class II 1987-10-29
K873518 AFFINITY TOTAL THYROXINE IMMUNIT Bd Becton Dickinson Vacutainer Systems Preanalytic KLI Class II 1987-10-29
K873994 EASY-TEST ALBUMIN (ALB), ITEM NO. 19039 Em Diagnostic Systems, Inc. CIX Class II 1987-10-29
K873635 EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021 Em Diagnostic Systems, Inc. CJE Class II 1987-10-29
K872120 SERALYZER III BLOOD CHEMISTRY ANALYZER Miles Laboratories, Inc. JJF Class I 1987-10-28
K873872 HCG ENZYME IMMUNOASSAY TEST KIT CATALOG #MB-1013 Medix Biotech, Inc. DHA Class II 1987-10-28
K874055 IRON REAGENT Trace Scientific , Ltd. JMO Class I 1987-10-28
K874038 MULTICHEM INORGANIC PHOSPHOROUS S0923 Simmler, Inc. CEO Class I 1987-10-28
K873128 GLUCOSE REAGENT KIT A-Kem, Inc. CGA Class II 1987-10-23
K873129 CARBON DIOXIDE REAGENT KIT A-Kem, Inc. JFL Class II 1987-10-23
K873126 SODIUM/POTASSIUM REAGENT KIT A-Kem, Inc. JGS Class II 1987-10-23
K873130 WASH SOLUTION KIT A-Kem, Inc. JJE Class I 1987-10-23
K873132 BUN REAGENT KIT A-Kem, Inc. LFP Class II 1987-10-23
K872879 DHEA-S RIA KIT Endocrine Associates, Inc. JKC Class I 1987-10-23

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