meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
60
Latest Decision
1980-11-12

Clearances · page 115 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K802470 T3 RADIOIMMUNOASSAY KIT American Diagnostic Corp. CDP Class II 1980-11-12
K802592 PARAGON SERUM PROTEIN ELECTROPHORESIS Beckman Instruments, Inc. CEF Class I 1980-11-12
K802450 GESTATE SLIDE EIKEN KIT AGG. METHOD HUM Syn-Kit, Inc. JHJ Class II 1980-10-31
K801848 ICA1 IONIZED CALCIUM ANALYZER The London Co. JFP Class II 1980-10-31
K802264 WASH SOLUTION KIT, #88102 Hi Chem, Inc. JJF Class I 1980-10-31
K802398 ELECTROLY TE CHEMISTRY ANALYZER Instrumentation Laboratory CO JJF Class I 1980-10-31
K802320 COULTER DACOS SERUM CHEM. ANALYZER Coulter Electronics, Inc. JJE Class I 1980-10-31
K802420 CENTRIFICHEM INORGANIC PHOSPHORUS Union Carbide Corp. CED Class I 1980-10-31
K802464 OREAI-Q-TU TEST Organon, Inc. KHQ Class II 1980-10-31
K802379 HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER American Instrument Co. LCH Class I 1980-10-31
K801729 ANDROSTENEDIONE RADIOIMMUNOASSAY KIT Diagnostics Biochem Canada, Inc. CIZ Class I 1980-10-31
K802467 TSH RADIOIMMUNOASSAY KIT American Diagnostic Corp. JLW Class II 1980-10-31
K802456 T4-SQUIBB RIA KIT E. R. Squibb & Sons, Inc. CDX Class II 1980-10-31
K802619 DRUG DETECTION SYSTEM Syva Co. JJQ Class I 1980-10-31
K802380 ARIA II 125 I CORTISOL Bd Becton Dickinson Vacutainer Systems Preanalytic CGR Class II 1980-10-31
K802455 ESTRIOL-SQUIBB RIA KIT E. R. Squibb & Sons, Inc. CGI Class I 1980-10-31
K802468 T3 UPTAKE TEST SYSTEM American Diagnostic Corp. KHQ Class II 1980-10-31
K802436 CENTRIFICHEM ALBUMIN Union Carbide Corp. CIX Class II 1980-10-31
K802435 UCG-BETA SLIDE Armkel, LLC JHJ Class II 1980-10-23
K802195 DEHYDROEPIANDROSTERONE SULFATE KIT RIA Radioassay Systems Laboratories, Inc. JKC Class I 1980-10-23
K802256 TRIGLYCERIDES DETERMINATION Coleman Laboratories Corp. CDT Class I 1980-10-23
K801578 COMBOSTAT - NO-BOIL KIT Ria Products, Inc. CDD Class II 1980-10-23
K802251 SP 120 SOPHISTICATE Vickers America Medical Corp. JQP Class I 1980-10-23
K802371 URIC ACID/ALDH Boehringer Mannheim Corp. CDO Class I 1980-10-23
K802209 SURETY COLUMN Scientific Specialties, Inc. JKA Class II 1980-10-23
K801892 KLINAR REAGENT PAK, #36010 Hi Chem, Inc. JGT Class II 1980-10-23
K802421 UCG-BETA STAT Armkel, LLC JHJ Class II 1980-10-23
K802310 IL TOTAL PROTEIN REAGENT Instrumentation Laboratory CO CEK Class II 1980-10-23
K802246 ANALYTE T3 UPTAKE Technicon Instruments Corp. KHQ Class II 1980-10-23
K802392 ASTRA PRINTER PAPER #88112-CHLORIDE SILV Hi Chem, Inc. JJF Class I 1980-10-23
K802376 KODAK EKTA-CHEM CLINICAL CHEM. SLIDES Eastman Kodak Company CHS Class II 1980-10-23
K802211 SERUM SEPARATOR Scientific Specialties, Inc. JKA Class II 1980-10-23
K801579 VITAMIN B12 - NO-BOIL KIT Ria Products, Inc. CDD Class II 1980-10-23
K802036 CORTISOL125 RADIOIMMUNOASSAY Corning Medical & Scientific CGR Class II 1980-10-23
K802120 HEPA-SHURE -L Nuclear Medical Laboratories, Inc. JJK Class I 1980-10-20
K801898 URIC ACID DIAGNOSTIC REAGENT Connecticut Diagnostics, Ltd. KNK Class I 1980-10-10
K802158 POSTASSIUM BUFFER SOL. & WASH SOLUTION Panmed, Inc. CEM Class II 1980-10-10
K802162 CO2 COLOR REAGENT & CO2 SAMPLE DILUENT Panmed, Inc. KMS Class II 1980-10-10
K802109 KEMTROL SERUM CONTROL ABNORMAL Helena Laboratories JJY Class I 1980-10-10
K802154 REAGENTS USED-QUAN. MEASURE OF SERUM Panmed, Inc. CIG Class II 1980-10-10
K802334 IN-HOME EARLY PREGNANCY TEST KIT Health Diagnostics Corp. JHJ Class II 1980-10-10
K802136 DELTA TEST TRIGLYCERIDES Bd Becton Dickinson Vacutainer Systems Preanalytic CDT Class I 1980-10-10
K802108 KEMTROL SERUM CONTROL-NORMAL Helena Laboratories JJY Class I 1980-10-10
K802135 TESTOSTERONE RADIOIMMUNOASSY KIT Radioimmunoassay, Inc. CDZ Class I 1980-10-10
K802157 BCG REAGENT SERUM ALBUMIN W/TECHNICON Panmed, Inc. CIX Class II 1980-10-10
K802155 REAGENTS SERUM SODIUM USING THE TECH. Panmed, Inc. JGS Class II 1980-10-10
K802343 PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO Intl. Diagnostic, Inc. JHJ Class II 1980-10-10
K802091 AMERICAN MONITOR MAGNESIUM #'S 1036&4021 American Monitor Corp. JGJ Class I 1980-10-10
K802159 AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS Panmed, Inc. CEO Class I 1980-10-10
K802068 ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO Beckman Instruments, Inc. JJX Class I 1980-10-10
K801897 GLUCOSE DIAGNOSTIC REAGENT Connecticut Diagnostics, Ltd. CGA Class II 1980-10-10
K802160 BUN COLOR REAGENT & BUN ACID USED Panmed, Inc. CDW Class II 1980-10-10
K802161 BIURET REAGENT & TOTAL PROTEIN BLANK SOL Panmed, Inc. CEK Class II 1980-10-10
K802163 CHLORIDE COLOR & CHLORIDE SAMPLE DILUENT Panmed, Inc. CHJ Class II 1980-10-10
K802164 8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM. Panmed, Inc. CIC Class II 1980-10-10
K802080 BAKER DIAG. ULTRARATE CHLORIDE KIT J.T. Baker Chemical Co. JFS Class II 1980-10-10
K802156 REAGENTS SERUM CREATINE USING TECHICON Panmed, Inc. CGX Class II 1980-10-10
K801456 F/LS MCA APPLICATION SOFTWARE Instrumentation Laboratory CO CFR Class II 1980-10-03
K801988 NORDICLAB PROSTATIC ACID PHOSPHATASE RIA Nordiclab Intl. JFH Class II 1980-09-26
K802064 DUPONT ACALACTIC ACID (LA) TEST E.I. Dupont DE Nemours & Co., Inc. KHP Class I 1980-09-26
K802061 DATA-ZYME UREA NITROGEN REAGENT SET Data Medical Associates, Inc. CDQ Class II 1980-09-26
K802035 BAKER DIAG. ULTRARATE CO2 REAGENT KIT J.T. Baker Chemical Co. JFL Class II 1980-09-26
K802210 CONICAL TIPPED CENTRIFUGE TUBE 15M Scientific Specialties, Inc. JQC Class I 1980-09-26
K801728 EMBRIA-CK Intl. Immunoassay Laboratories, Inc. JHX Class II 1980-09-26
K801501 UV URIC ACID STANDARDS The Dow Chemical Co. JIS Class II 1980-09-26
K801957 MICRO-FLOW SPECTROPHOTOMETER CL-720 Shimadzu Precision Instruments, Inc. JJQ Class I 1980-09-26
K801889 MODEL 203S CLINICAL CHEMISTRY ANALYZER Gilford Instrument Laboratories, Inc. JJE Class I 1980-09-26
K801913 MICROLAB M-MICROPROCESSOR DILUTER/DISP Hamilton Co. JQW Class I 1980-09-26
K801851 CENTRIFICHEM PIPETTOR 1000 Union Carbide Corp. JQW Class I 1980-09-16
K801795 BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. J.T. Baker Chemical Co. JGS Class II 1980-09-16
K801735 ARIA II 125- I-ESTRIOL SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic CGI Class I 1980-09-16
K801891 WAKO TRIGLYCERIDE-G TEST Wako Pure Chemical Industries, Ltd. CDT Class I 1980-09-16
K801749 BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM Beckman Instruments, Inc. CEK Class II 1980-09-16
K801765 GLUCOSE REAGENT(UV-HEXOKINASE) Reagents Applications, Inc. CFR Class II 1980-09-16
K801536 BLOOD GLUCOSE TESTER Broomer Research Corp. JJQ Class I 1980-09-16
K801882 NOVA 4 SODIUM/POTASSIUM/CHLORIDE/CARBON Nova Biomedical Corp. JGS Class II 1980-09-16
K801896 BECKMAN ELECTROLYTE-2 SODIUM/POTASSIUM Beckman Instruments, Inc. JGS Class II 1980-09-16
K802031 3390A REPORTING INTEGRATOR Hewlett-Packard Co. LDM Class I 1980-09-16
K801843 T3(125) RADIOIMMUNOASSAY KIT Technia Diagnostics , Ltd. CDP Class II 1980-09-16
K801857 DATA-ZYME LAT(GPT) PROCEDURE Data Medical Associates, Inc. CKA Class I 1980-09-16
K801849 LACTI-QUANT Nuclear Medical Laboratories, Inc. CFT Class I 1980-09-16
K801854 SPINAL FLUID CONTROL(HUMAN) Environmental Chemical Specialties JJX Class I 1980-09-16
K801856 DATA-ZYME AST(GOT) PROCEDURE Data Medical Associates, Inc. CIT Class II 1980-09-16
K801834 WAKO HDL CHOLESTEROL TEST Wako Pure Chemical Industries, Ltd. LBS Class I 1980-09-16
K801750 BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY Beckman Instruments, Inc. CIX Class II 1980-09-16
K801893 CORNING 60 VOLT POWER SUPPLY Corning Medical & Scientific JJN Class I 1980-09-16
K801727 DATA-ZYME UREA NITROGEN, COLORIMETRIC Data Medical Associates, Inc. CDL Class II 1980-09-09
K801538 ASSURE LEVEL I PROD. #30171 Warner-Lambert Co. JJY Class I 1980-09-09
K801726 HDL CHOLESTEROL TEST KIT Mallinckrodt Critical Care LBS Class I 1980-09-09
K801539 ASSURE LEVEL II PROD. #30172 Warner-Lambert Co. JJY Class I 1980-09-09
K801666 TESTOSTERONE KIT Immuchem Corp. CDZ Class I 1980-08-27
K801833 GAS-CHROMATOGRAPHIC PACKING Supelco, Inc. DJA Class I 1980-08-27
K801600 GLUCOSE (TRINDER) REAGENT Gilford Diagnostics CGA Class II 1980-08-27
K801691 TSH RIASSAY Ria Diagnostics JLW Class II 1980-08-27
K801664 SERALYZER GLUCOSE TEST MODULE Miles Laboratories, Inc. JQP Class I 1980-08-20
K801665 SERALYZER GLUCOSE CALIBRATORS(LOW&HIGH) Miles Laboratories, Inc. JIS Class II 1980-08-20
K801564 PHOTOMETER LP 1 Dr. Bruno Lange GmbH JJQ Class I 1980-08-20
K801649 KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES Eastman Kodak Company KNK Class I 1980-08-20
K801745 VISTA 44 GAS CHROMATOGRAPHY ANALYSIS Varian Assoc., Inc. KZQ Class I 1980-08-20
K801563 PHOTOMETER LP 3 Dr. Bruno Lange GmbH JJQ Class I 1980-08-20

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