meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
68
Latest Decision
1980-08-20

Clearances · page 116 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K801500 ULTRAFREE CALCIUM FILTER Millipore Corp. JRL Class I 1980-08-20
K801599 CORNING 184 BLOOD GAS TONOMETER Corning Medical & Scientific LCH Class I 1980-08-20
K801772 MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG Radiation Technology, Inc. JJH Class I 1980-08-20
K801663 SERALYZER GLUCOSE REAGENT STRIPS Miles Laboratories, Inc. CGA Class II 1980-08-20
K801481 BMC RIAFLO SYSTEM Boehringer Mannheim Corp. JJC Class I 1980-08-20
K801562 PHOTOMETER LP 6 Dr. Bruno Lange GmbH JJQ Class I 1980-08-20
K801668 QUICK CEPT Laboratory Diagnostics Co., Inc. JHS Class II 1980-08-13
K801491 MRI HCG-BETA RIA KIT CAT. #MR-10100 Microanalytic Research, Inc. JHI Class II 1980-08-13
K801499 AGA UV PHOTOMETER Syva Co. JJQ Class I 1980-08-13
K801560 VENTREX/SEP TSH TEST SET Ventrex Laboratories, Inc. JLW Class II 1980-08-13
K800587 NSI WASH SOLUTION CONCENTRATE Nobel Scientific Industries, Inc. JJC Class I 1980-08-08
K801438 CENTRIFICHEM SYSTEM MANAGER Union Carbide Corp. JQP Class I 1980-07-28
K801285 YSI MODELS 23C & 23CM HDL & TOTAL CHOLES Yellow Springs Instrument Co., Inc. CHH Class I 1980-07-28
K801061 TOTAL PROTEIN TEST Environmental Chemical Specialties CEK Class II 1980-07-21
K801362 ALBUMIN NEPHELOMETRIC ASSAY J.T. Baker Chemical Co. JQX Class I 1980-07-21
K801198 FOLATE RADIOASSAY KIT Calbiochem-Behring Corp. CGN Class II 1980-07-21
K801424 ESTRIOL RIA KIT FOR USE WITH GAMMAFLO Squibb & Sons, Inc. CGI Class I 1980-07-21
K801449 BLOOD GAS CONTROL PROD. NO. BG-1, BG-2 Health Diagnostics Corp. JJS Class I 1980-07-21
K801439 MODEL 5100 ELECTROCHEMICAL DETECTOR Environmental Sciences Assoc., Inc. LEQ Class I 1980-07-21
K801318 HELENA ULTRA SENSITIVE CPK REAGENT/DILUE Helena Laboratories JHX Class II 1980-07-14
K801373 BECKMAN MODEL 42 SPECTROPHOTOMETER Beckman Instruments, Inc. JJQ Class I 1980-07-14
K801409 GAMMADAB B-HCG RADIOIMMUNOASSAY KIT Travenol Laboratories, S.A. JHI Class II 1980-07-14
K801378 HIPP BUFFER(NON-BARBITAL), P/N Gelman Sciences, Inc. JJN Class I 1980-07-14
K801299 COBAS CK-NAC REAGENT Roche Analytical Instruments, Inc. CGS Class II 1980-07-14
K801270 TEST FOR KETONE IN URINE(ACETOACETIC AC Miles Laboratories, Inc. JIN Class I 1980-07-08
K801475 APPLICATION OF EMIT AED ASSAYS Syva Co. KLI Class II 1980-07-08
K801020 GAMMA PROLACTIN RADIOIMMUNOASSAY KIT- Travenol Laboratories, S.A. CFT Class I 1980-07-08
K801335 UNASSAYED CHEMISTRY SERUM CONTROL(BOVINE Warner-Lambert Co. JJY Class I 1980-07-08
K801298 COBAS REAGENT FOR TRIGLYCERIDES & COBAS Roche Analytical Instruments, Inc. CDT Class I 1980-07-08
K801300 DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL) E.I. Dupont DE Nemours & Co., Inc. JIW Class II 1980-07-08
K801269 SERALYZER BLOOD UREA NITROGEN(BUN) Miles Laboratories, Inc. JGZ Class II 1980-07-08
K801011 AVL #980 ELECTROLYTE ANALYZER Gauntlet Technology Corp. JGS Class II 1980-07-08
K801295 COBAS REAGENT FOR A-AMYLASE Roche Analytical Instruments, Inc. JFJ Class II 1980-07-08
K801076 WAKO PHOSPHOLIPIDS TEST Wako Pure Chemical Industries, Ltd. CEL Class I 1980-06-30
K801290 ALIZARIN SULFONATE, CALCIUM Union Carbide Corp. CID Class II 1980-06-30
K801297 COBAS REAGENT FOR GLUCOSE RAPID Roche Analytical Instruments, Inc. CFR Class II 1980-06-30
K801287 EMIT AAII THYROXINE CALIBRATORS Syva Co. JIS Class II 1980-06-30
K801288 EMIT AAII THYROXINE ASSAY Syva Co. KLI Class II 1980-06-30
K801296 COBAS REAGENT FOR CHOLESTEROL Roche Analytical Instruments, Inc. CHH Class I 1980-06-30
K801264 NUCLEAR ENTERPRISES 1600/GAMMA COUNTER Nuclear Ent. , Ltd. JJJ Class I 1980-06-26
K801243 COBAS REAGENTS FOR URIC ACID Roche Analytical Instruments, Inc. CDO Class I 1980-06-26
K801222 REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER Simmler, Inc. JIX Class II 1980-06-26
K801226 TRIGLYCERIDES FOR SMA AND AAII Reagents Applications, Inc. CDT Class I 1980-06-20
K801244 ROCHE HCG STANDARDS Hoffmann-La Roche, Inc. JHI Class II 1980-06-20
K801242 COBAS REAGENT FOR ALKALINE PHOSPHATASE Roche Analytical Instruments, Inc. CJE Class II 1980-06-20
K800911 A-GENT THYROZYME UPTAKE INHIBITOR ASSAY Abbott Laboratories KHQ Class II 1980-06-20
K801245 ATOMLIGHT (LIQUID SCINTILLATION SOLUTION New England Nuclear JJJ Class I 1980-06-20
K801118 COBAS REAGENT FOR AST (SGOT) Roche Analytical Instruments, Inc. CIT Class II 1980-06-20
K801263 NUCLEAR ENTERPRISES 1612 MULTI-WELL Nuclear Ent. , Ltd. JJJ Class I 1980-06-20
K801116 COBAS REAGENT FOR BUN Roche Analytical Instruments, Inc. CDQ Class II 1980-06-17
K801133 CENTRIFICHEM HDL CHOLESTEROL Union Carbide Corp. LBS Class I 1980-06-17
K801210 BIOSTATOR PRINTER/PLOTTER Miles Laboratories, Inc. JQP Class I 1980-06-17
K801117 COBAS TOTAL BILIRUBIN REAGENT & DILUENT Roche Analytical Instruments, Inc. CIG Class II 1980-06-09
K801096 PERKIN ELMER MODEL 91 AMYLASE REAGENT Stat Engineering KHM Class II 1980-06-09
K801167 CENTRIFICHEM SYSTEM 400 Union Carbide Corp. JQP Class I 1980-06-09
K801145 SMI MULTI-TUBE VORTEXER Scientific Manufacturing Industries JRQ Class I 1980-06-09
K801091 K 750 COMPUTER/DATA PROCESSOR J.T. Baker Chemical Co. JQP Class I 1980-06-09
K801203 CORTISOL RADIOIMMUNOASSAY KIT Technia Diagnostics , Ltd. CGR Class II 1980-06-09
K801125 SPAC T3 RIA TEST KIT Mallinckrodt Critical Care CDP Class II 1980-06-09
K801123 TRIIODOTHYRONINE RADIOIMMUN. SYSTEM Calbiochem-Behring Corp. CDP Class II 1980-06-09
K801105 THYROXINE RADIOIMMUNOASSAY KIT Calbiochem-Behring Corp. CDX Class II 1980-06-09
K801139 CENTRIFICHEM SYSTEM 500 ANALYZER Union Carbide Corp. JJG Class I 1980-06-09
K801090 J.T. BAKER LSA 290 PIPETTER/DILUTER J.T. Baker Chemical Co. JQW Class I 1980-06-09
K801271 MODEL 4900 OFF-LINE PREPARATION SYSTEM Pm America, Inc. JQW Class I 1980-06-09
K801148 HEMOGASTAT Therapac, Inc. JRR Class I 1980-06-09
K800902 BUN-COLOR 2, BLOOD UREA NITROGEN TEST Sclavo, Inc. CDL Class II 1980-06-09
K801119 COBAS REAGENT FOR ALT (GPT) Roche Analytical Instruments, Inc. CKA Class I 1980-06-09
K801044 AMES GLUCOMETER REFLECT. PHOTOMETER Miles Laboratories, Inc. JJQ Class I 1980-06-02
K800681 REAGENTS FOR DETERM. CO2 IN HUMAN SERUM Diagnostic Solutions, Inc. KMS Class II 1980-05-30
K800689 REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- Diagnostic Solutions, Inc. CKA Class I 1980-05-30
K800686 REAGENT FOR DETERM. DIRECT BILIRUBIN Diagnostic Solutions, Inc. CIG Class II 1980-05-28
K800690 REAGENT FOR DETERM. INORGANIC/PHOSPHORUS Diagnostic Solutions, Inc. CEO Class I 1980-05-28
K801026 IL MODEL 773 FLUORESCENCE LIGHT SCATTER Instrumentation Laboratory CO JJG Class I 1980-05-28
K800683 REAGENT FOR DETERM. CHLORIDE IN HUMAN/SM Diagnostic Solutions, Inc. CHJ Class II 1980-05-28
K800691 REAGENT FOR DETERM. LACTATE/DEHYDROGENAS Diagnostic Solutions, Inc. CFJ Class II 1980-05-28
K801030 RIAUSE AUTO PROCESSOR Electro-Nucleonics Laboratories, Inc. JQW Class I 1980-05-28
K801037 CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA Union Carbide Corp. LCI Class I 1980-05-28
K801089 J.T. BAKER NEPHELOMETER J.T. Baker Chemical Co. JQX Class I 1980-05-28
K800679 REAGENTS FOR DETERM. ALKALINE PHOSPHATAS Diagnostic Solutions, Inc. CJE Class II 1980-05-28
K800673 SMAC REPLACEMENT REAGENTS/OF BUN-SERUM Diagnostic Solutions, Inc. CDW Class II 1980-05-28
K800676 REAGENTS FOR DETERM. SODIUM IN HUMAN SUM Diagnostic Solutions, Inc. JGS Class II 1980-05-28
K800674 SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER Diagnostic Solutions, Inc. CEK Class II 1980-05-28
K800687 REAGENT FOR DETERM. GLUCOSE IN H/SERUM Diagnostic Solutions, Inc. CGA Class II 1980-05-28
K800682 REAGENTS FOR DETERM. CHOLESTEROL/SERUM Diagnostic Solutions, Inc. CGO Class I 1980-05-28
K800692 REAGENT FOR DETERM. POTASSIUM/IN HUMAN Diagnostic Solutions, Inc. CEM Class II 1980-05-28
K800680 REAGENTS FOR DETERM. CALCIUM IN HUMAN Diagnostic Solutions, Inc. CIC Class II 1980-05-28
K800672 SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC Diagnostic Solutions, Inc. CDH Class I 1980-05-28
K800678 REAGENTS FOR DETERM. ALBUMIN IN HUMAN Diagnostic Solutions, Inc. CIX Class II 1980-05-28
K800688 REAGENT FOR DETERM. GLUTAMIC-OXALOACETIC Diagnostic Solutions, Inc. CIT Class II 1980-05-28
K800684 REAGENT FOR DETERM. CREATINE PHOSPHOKINA Diagnostic Solutions, Inc. JHY Class II 1980-05-28
K800685 REAGENT FOR DETERM. CREATININE IN H/SERU Diagnostic Solutions, Inc. CGX Class II 1980-05-28
K800675 REAGENTS FOR DETERM. TOTAL BILIRUBIN Diagnostic Solutions, Inc. CIG Class II 1980-05-28
K800677 REAGENTS FOR DETERM. SERUM IRON IN HUMAN Diagnostic Solutions, Inc. JIY Class I 1980-05-28
K801052 DATA-ZYME GLUCOSE HEXOKINASE UV Data Medical Associates, Inc. CFR Class II 1980-05-23
K801071 LANCER GLUCOSE RATE REAGENT KIT Sherwood Medical Industries CGA Class II 1980-05-23
K801131 IL88640 & 88641 CASSETTE-TAPE PROGRAM Instrumentation Laboratory CO JQP Class I 1980-05-23
K801051 DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI Data Medical Associates, Inc. CFR Class II 1980-05-23
K801007 IL SYSTEM 502 NA/K ANALYZER Instrumentation Laboratory CO JGS Class II 1980-05-14
K800920 NORDICLAB ESTRADIOL RIA TEST Nordiclab Intl. CHP Class I 1980-05-14
K800922 NORDICLAB PROGESTERONE RIA TEST Nordiclab Intl. JLS Class I 1980-05-14

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