meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
63
Latest Decision
1981-01-26

Clearances · page 114 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K810084 MAGNESIUM KIT Bio-Analytics Laboratories, Inc. JGJ Class I 1981-01-26
K810090 CHOLESTEROL REAGENT Anco Medical Reagents & Assoc. CGO Class I 1981-01-26
K810082 ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT Bio-Analytics Laboratories, Inc. CJE Class II 1981-01-26
K810063 AUTOMATIC BIOCHEMICAL ANALYZER Acculab JQP Class I 1981-01-26
K810091 GLUCOSE STANDARD Anco Medical Reagents & Assoc. JIS Class II 1981-01-26
K810107 RESPA-TROL Intensive Technology, Inc. JJS Class I 1981-01-26
K810033 CORTI-SHURE Nuclear Medical Laboratories, Inc. CGR Class II 1981-01-21
K803278 LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT Immuno Nuclear Corp. CEP Class I 1981-01-21
K802754 IMMUNOREACTIVE ESTRIOL RIA KIT Microanalytic Research, Inc. CGI Class I 1981-01-21
K803273 PROLACTIN (125) RADIOIMMUNAOASSAY Corning Medical & Scientific CFT Class I 1981-01-16
K810001 'NO-BOIL' DUALCOUNT KIT Diagnostic Products Corp. CGN Class II 1981-01-16
K803296 ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT Immunotech Corp. KWW Class II 1981-01-16
K803297 LUQUIZYME TRIGLYCERIDE REAGENT SET Amresco, Inc. CDT Class I 1981-01-16
K803301 CREATINE KINASE REAGENT Gilford Diagnostics CGS Class II 1981-01-16
K803279 FOLLICE STIMULATING HORMONE-RADIOIMM. KT Immuno Nuclear Corp. CGJ Class I 1981-01-16
K803285 PHOTOMETER Turner Designs, Inc. JJQ Class I 1981-01-16
K803305 DUPONT 'ACA' CREATINE KINASE VERIFIERS E.I. Dupont DE Nemours & Co., Inc. JJT Class I 1981-01-16
K803280 HUMAN GROWTH HORMONE-RADIOIMM. KIT Immuno Nuclear Corp. CFL Class I 1981-01-16
K803287 CHOLESTEROL REAGENT ENZYMATIC Rai, Inc. CHH Class I 1981-01-16
K803182 SYRINGE FOR BLOOD SAMPLING The University of Chicago GIM Class II 1981-01-16
K810002 'NO-BOIL' VITAMIN B12 KIT Diagnostic Products Corp. CDD Class II 1981-01-16
K803281 AUTOMATED ELECTROPHORESIS SYSTEM Helena Laboratories JJN Class I 1981-01-16
K803267 AUTOMATED IMMUOCHEMISTRY SYSTEM Beckman Instruments, Inc. JJE Class I 1981-01-16
K803261 T3 RIABEAD DIAGNOSTIC KIT Abbott Laboratories CDP Class II 1981-01-15
K803131 LKB-WALLACE 1250 LUMINOMETER Lkb Instruments, Inc. JJQ Class I 1981-01-15
K803254 LIQUID-STAT REAGENT FOR ASSAY OF CHOLES. Beckman Instruments, Inc. CHH Class I 1981-01-09
K802826 PARAGON ELECTRO. CREATINE KINASE TEST KI Beckman Instruments, Inc. JHX Class II 1981-01-09
K803091 TRIGLYCERIDES (UV)-2 REAGENTS Reagents Applications, Inc. CDT Class I 1981-01-09
K802451 BLF EIKEN KIT DETER. OF B-LIPOPR. FRAC. Syn-Kit, Inc. JHQ Class I 1981-01-09
K803168 CARDIO ZYME PLUS CK-MB #65045 Harleco JHW Class II 1981-01-09
K803169 CARDIOZYME PLUS CK-TOTAL #65046 Harleco JHS Class II 1981-01-09
K802220 VITAMIN B12 (57CO) RADIOIMMUNOASSAY Corning Medical & Scientific CDD Class II 1981-01-09
K803237 AMES SERA-PAK ALBUMIN REAGENT KIT Miles Laboratories, Inc. CIX Class II 1981-01-09
K803051 FLAME PHOTOMETRY REAGENTS Laboratory Products, Inc. JIX Class II 1981-01-09
K803098 TRI-LEVEL RADIOASSAY CONTROL SERA American Diagnostic Corp. JJY Class I 1981-01-09
K803216 CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT Union Carbide Corp. CIT Class II 1981-01-09
K803135 PARALLEL CHEMICAL ANALYZER American Monitor Corp. JJE Class I 1981-01-09
K803180 1-125 LABELED TRIIODOTHYRONINE(T3) Pcl-Ria, Inc. CDP Class II 1981-01-09
K803240 CORNING 760 FLUOROMETER/DENSITOMETER Transidyne General Corp. JQT Class I 1981-01-09
K803013 CHLORIDE/TCO2 ANALYZER REAGENTS Laboratory Products, Inc. CHJ Class II 1981-01-02
K803088 MAGNESIUM TEST KIT Mallinckrodt Critical Care JGJ Class I 1981-01-02
K803089 GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) Environmental Chemical Specialties JPZ Class I 1981-01-02
K803044 IMMU-TRACE T3 UPTAKE (T3U) REAGENTS American Dade KHQ Class II 1981-01-02
K803001 LEECO TESTO-QUANT DIAGNOSTIC KIT Leeco Diagnostics, Inc. CDZ Class I 1981-01-02
K803043 RIAPHASE (125I) PROST. ACID PHOSPH. KIT Beckman Instruments, Inc. JFH Class II 1981-01-02
K803046 IMMU-TRACE T4 RIA PROCEDURE American Dade CDX Class II 1981-01-02
K803087 LANCER CREATININE MICROSAMPLE STAT ANA Sherwood Medical Co. CGX Class II 1981-01-02
K802969 CORTISOL 125-I RADIOIMMUNOASSAY KIT Ria Products, Inc. CGR Class II 1981-01-02
K803004 AMINO ACID ANALYSER SYSTEM Lkb Instruments, Inc. JJF Class I 1980-12-22
K803030 THE BIO-TEK CHROMOSCAN Bio-Tek Instruments, Inc. JJQ Class I 1980-12-22
K802997 HDL-CHOLESTEROL CONTROL SERUM Isolab, Inc. JJX Class I 1980-12-22
K803092 MIC-BIOPLATE INOCULATOR Pasco Laboratories, Inc. JQW Class I 1980-12-22
K802944 QUANTIMUNE E3 RIA Bio-Rad CGI Class I 1980-12-22
K803060 FOLATE 125I RADIOIMMUNOASSAY Corning Medical & Scientific CGN Class II 1980-12-22
K803019 SERALYZER LDH REAGENT STRIPS, CALIBR Miles Laboratories, Inc. CFJ Class II 1980-12-22
K802999 BETA-TEC QUALITATIVE Armkel, LLC JHI Class II 1980-12-22
K802962 CHEM-ASSAY STANDARD-CONTROLS National Bio-Technical Laboratories JJY Class I 1980-12-22
K802974 RAPI-DOT Organon, Inc. JHJ Class II 1980-12-19
K802959 NIKON URINE REFRACTOMER SG-1 Nippon Kogaku, Inc. JRE Class I 1980-12-19
K802923 BECKMAN ASTRA SYSTEMS CALCIUM CHEMISTRY Beckman Instruments, Inc. CIC Class II 1980-12-19
K802883 T3-SQUIBB RIA KIT E. R. Squibb & Sons, Inc. CDP Class II 1980-12-19
K802842 SINGLE VIAL LIPASE TEST KIT Biodynamics Corp. CHI Class I 1980-12-18
K802578 PACE-4-AUTOMATIC RIA GAMMA-COUTER Philips Medical Systems (Cleveland), Inc. JJJ Class I 1980-12-18
K802822 PARAGON LIPOPROTEIN ELECTRO. REAG. KIT Beckman Instruments, Inc. JHO Class I 1980-12-11
K802632 ALBUMIN/TOTAL PROTEIN STANDARDS Gilford Diagnostics JIX Class II 1980-12-11
K802725 VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS Varian Assoc., Inc. KZR Class I 1980-12-11
K802823 CHOLESTEROL STANDARDS Mallinckrodt Critical Care JIT Class II 1980-12-11
K802631 CREATININE STANDARDS Gilford Diagnostics JIS Class II 1980-12-11
K802825 COMBINED GLUCOSE AND BUN STANDARDS Mallinckrodt Critical Care JIX Class II 1980-12-11
K802824 COMBUNED CALCIUM AND PHOSPHORUS STD. Mallinckrodt Critical Care JIX Class II 1980-12-11
K802835 COMPU-CHEM II CHEMISTRY ANALYZER Diagnostic Aids, Inc. JJE Class I 1980-12-11
K802633 BUN/GLUCOSE STANDARDS Gilford Diagnostics JIX Class II 1980-12-11
K802728 125I-TESTOSTERONE TEST SET Wien Laboratories, Inc. CDZ Class I 1980-12-11
K802628 PARAGON ELECTROPHORESIS LACTATE REAG.KIT Beckman Instruments, Inc. CFE Class II 1980-12-11
K802693 OREIA-Q-TY, ENZYME IMMUNOASSAY Organon, Inc. KLI Class II 1980-12-10
K802743 AMES SERA-PAK CHOLESTEROL REAGENT KIT Miles Laboratories, Inc. CHH Class I 1980-12-10
K802692 LANCER URIC ACID AUTO/STAT KIT Sherwood Medical Co. KNK Class I 1980-12-10
K802741 CENTRIFICHEM COMB. SERUM-BASED CALIB. Union Carbide Corp. JIX Class II 1980-12-10
K802810 HEXOKINASE, GLUCOSE Beckman Instruments, Inc. CFR Class II 1980-12-10
K802724 AMES SERA-PAK URIC ACID REAGENT KIT Miles Laboratories, Inc. KNK Class I 1980-12-10
K802661 LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT Damon Corp. CDZ Class I 1980-12-10
K802609 CHEMISTRY ANALYZER IMPACT 400 Gilford Instrument Laboratories, Inc. JJE Class I 1980-11-26
K802396 GENERAL PROCEDURE AGAROSE FILM Electrophoresis Corp. of America JJN Class I 1980-11-26
K802395 SPECIAL PROCEDURE AQAROSE FILM Electrophoresis Corp. JJN Class I 1980-11-26
K802630 CAFFEINE REAGENT DIAZO COLORIMETRY American Monitor Corp. CIG Class II 1980-11-26
K802660 ANSWER AT-HOME PREGNANCY TEST KIT Armkel, LLC JHJ Class II 1980-11-24
K802573 SERUM T4 BY ENZYME IMMUNOASSAY Worthington Diagnostic Systems CDX Class II 1980-11-24
K802581 BEKCMAN ASTRA SYSTEMS AMYLASE CHEMISTRY Beckman Instruments, Inc. JFJ Class II 1980-11-12
K802703 LIQUID CHROMATOGRAPHY COLUMNS Supelco, Inc. DPM Class I 1980-11-12
K802521 CK-MB(IMMUNOLOGICAL) Biodynamics Corp. JHS Class II 1980-11-12
K802520 CENTRIFICHEM PIPETTOR ACCURACY CALIB. Union Carbide Corp. JQW Class I 1980-11-12
K802594 BECKMAN DP-5500 DATA REDUCTION SYSTEM Beckman Instruments, Inc. JQP Class I 1980-11-12
K802454 GESTE FOLLOW KIT DETERM. OF HPL Syn-Kit, Inc. JMF Class II 1980-11-12
K802518 BUN REAGENT ASTRA 4 & 8 ANALYZERS Nobel Scientific Industries, Inc. CDN Class II 1980-11-12
K802579 CYBREX TM FPQ FLUORESCENE POLARIZATION Abbott Laboratories KHO Class I 1980-11-12
K802471 CHEMTROLER Fletcher Flora Computer Products, Inc. JQP Class I 1980-11-12
K802469 T4 RADIOIMMUNOASSAY KIT American Diagnostic Corp. CDX Class II 1980-11-12
K802574 BECKMAN LIQUID STAT LIQUID/ALKALINE PHO Beckman Instruments, Inc. CJE Class II 1980-11-12
K802572 BECKMAN LIQUID-STAT LD-L-UV ENZYME Beckman Instruments, Inc. CFJ Class II 1980-11-12
K802153 CBC PAP TEST KIT Calbiochem-Behring Corp. JFH Class II 1980-11-12

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