meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
59
Latest Decision
1983-02-25

Clearances · page 105 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K830301 STRATUS FLUOROMETRIC ENZYME IMMUN0- American Hospital Supply Corp. JJE Class I 1983-02-25
K830118 ALKALINE PHOSPHATES ISOENZYME SUBSTRATE Corning Medical & Scientific CIN Class II 1983-02-25
K830179 BIOCELL SPINAL FLUID CONTROL Biocell Laboratories, Inc. JJY Class I 1983-02-18
K830240 ULTRAZYME PLUS GAMMA GT-MCA #65055-65056 Emd Chemicals, Inc. JQB Class I 1983-02-18
K830238 ULTRA CHEM CRESOLCAVERSACHEM #65082 Emd Chemicals, Inc. CIC Class II 1983-02-18
K830195 NO BOIL DUAL COUNT VIT-B12 & FOLIC ACID Diagnostic Products Corp. CDD Class II 1983-02-18
K830204 DAC-CEL DIAGNATAL HCG STANDARDS RD49 Wellcome Diagnostics JJX Class I 1983-02-18
K830217 REAGENTS CORNING CHLORIDE METER FOR Fisher Scientific Co., LLC JFS Class II 1983-02-18
K830246 CAST SHOE, CAST BOOT Warm & Form, Orthopedic Materials JQB Class I 1983-02-18
K823766 BLOOD GAS INCUBATOR #260650 Boekel Industries, Inc. JRG Class I 1983-02-18
K830203 DAC-CEL DIAGNATAL RD 50 Wellcome Diagnostics JHI Class II 1983-02-18
K830091 LITH A TEST TM Lenal Creative Approaches, Inc. CEN Class I 1983-02-15
K830148 CORTISOL KIT Cambridge Medical Technology CGR Class II 1983-02-09
K830156 HCG SCREENING TEST Tago, Inc. JHJ Class II 1983-02-09
K823386 APSARA CLINICAL DIAG. & INFO. SYS Datachem, Inc. JJE Class I 1983-02-09
K830136 PARAMOUNT THYROXINE ASSAY Syva Co. KLI Class II 1983-02-07
K823352 IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS American Dade JJY Class I 1983-02-07
K830147 SIGMA 300 GAS CHROMATROGRAPH The Perkin-Elmer Corp. KZQ Class I 1983-02-07
K830138 TANDEM E GCG VISUAL END POINT INNUMOENZ Hybritech, Inc. JHI Class II 1983-02-07
K830137 CALIBRATOR A Hi Chem, Inc. JIS Class II 1983-02-07
K823389 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ Nova Biomedical Corp. JFP Class II 1983-02-02
K822709 URITEST 9, INLAB REAGENT STRIPS URINALY Laprol Scientific, Inc. JMA Class I 1983-01-28
K830101 COLORIMETERS SERIES ONE 12 Innotron of Oregon, Inc. JJQ Class I 1983-01-28
K830104 SERUM IRON DIAGNOSTIC TEST KITS Sclavo, Inc. CEM Class II 1983-01-28
K823929 MULTIANALYTE CONTROLS-ALL KINDS Fisher Scientific Co., LLC JJY Class I 1983-01-28
K823883 ULTRAZYME PLUS GAMMA-GT, #64959/65032 Emd Chemicals, Inc. JQB Class I 1983-01-28
K830036 NEONATAL NTSH RADIOIMMUNOASSAY SYS Corning Medical & Scientific JLW Class II 1983-01-28
K823504 CYCLIC ADENOSINE MONOPHOSHATE BY RADIO Immuno Nuclear Corp. CHO Class II 1983-01-28
K830032 TOTAL IRON BINDING CAPACITY TEST Sclavo, Inc. JQF Class I 1983-01-28
K830095 RAPID CHEM ANALYZER II Macomb Chemical Co. JJF Class I 1983-01-28
K823939 WAKO INSULIN TEST Wako Chemicals USA, Inc. CFP Class I 1983-01-28
K823846 URIC ACID TEST Scalavo, Inc. KNK Class I 1983-01-24
K823753 GENESIS B-HCG Armkel, LLC JHI Class II 1983-01-24
K823836 MONOJECT SAMPLETTE CAPILLARY BLOOD COLL Sherwood Medical Co. JKA Class II 1983-01-21
K823786 ALKALINE PHOSPHATASE Analytical & Research Chemicals, Inc. CJE Class II 1983-01-14
K823750 CLEANING AGENT Shaban Mfg. Co. CHL Class II 1983-01-14
K823784 ENZYMATIC CHOLESTEROL (COLORIMETRIC Analytical & Research Chemicals, Inc. CHH Class I 1983-01-14
K823806 DIRECT CREATININE PROCEDURE Analytical & Research Chemicals, Inc. CGX Class II 1983-01-14
K823762 VARIOUS-ANALYZER CUPS Cordis Corp. JJE Class I 1983-01-12
K823264 THYROXINE ANALYSIS PRODUCTS/RADIO-FREE Bd Becton Dickinson Vacutainer Systems Preanalytic CEC Class II 1983-01-12
K823756 ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082 Em Industries, Inc. CIC Class II 1983-01-12
K823751 SOPHEIA THYROXINE EIA KIT Diagnostic Products Corp. KLI Class II 1983-01-12
K823480 IL 943 FLAME PHOTOMETER Instrumentation Laboratory CO JJO Class I 1983-01-09
K823721 FLOW-PAC LDH REAGENT SET Amresco, Inc. CFJ Class II 1983-01-09
K823300 BUN-UN CENTRIFICHUM 500, #65080/81 Emd Chemicals, Inc. CDQ Class II 1983-01-09
K823785 API MDS* Analytical Products, Inc. JQP Class I 1983-01-09
K823580 COBAS REAGENT FOR INORGANIC PHOSPHORUS Hoffmann-La Roche, Inc. CEO Class I 1983-01-07
K823550 CK-ISOZYME U.V. REAGENT SET Gelman Sciences, Inc. JHT Class II 1983-01-07
K823186 ESTROCEPT STABILIZED ESTROGEN RECEPTOR Brl JJX Class I 1983-01-07
K823573 COBAS REAGENT FOR CREATININE Hoffmann-La Roche, Inc. CGX Class II 1983-01-07
K823720 SPECTROPHOTOMETER Macomb Chemical Co. JJQ Class I 1983-01-07
K823574 COBAS REAGENT FOR ALBUMIN Hoffmann-La Roche, Inc. CIX Class II 1983-01-07
K823691 PHOSPHORUS REAGENT SET Omega Medical Electronics CEO Class I 1983-01-07
K823572 COBAS STANDARDS FOR CREATININE Hoffmann-La Roche, Inc. CGX Class II 1983-01-07
K823577 COBAS REAGENT FOR CALCIUM Hoffmann-La Roche, Inc. CIC Class II 1983-01-07
K823579 COBAS REAGENT FOR TOTAL PROTEIN Hoffmann-La Roche, Inc. CEK Class II 1983-01-07
K823679 NML 6000 CT Nuclear Medical Laboratories, Inc. JQP Class I 1983-01-07
K823687 BIO INTERFERENCE BLANKING MATERIAL American Monitor Corp. JJX Class I 1983-01-07
K823682 BETA FFIRM TEST Organon, Inc. JHJ Class II 1983-01-07
K823709 TRIGLYCERIDE REAGENT (UV) Gilford Diagnostics CDT Class I 1983-01-07
K823575 COBAS STANDARDS FOR ALBUMIN Hoffmann-La Roche, Inc. CIX Class II 1983-01-07
K823578 COBAS STANDARDS FOR CALCIUM-IN-ORGANIC Hoffmann-La Roche, Inc. CIO Class II 1983-01-07
K823697 PREP TYPE A EXTRACTION CARTRIDGE E.I. Dupont DE Nemours & Co., Inc. DJY Class I 1983-01-05
K823688 DOUBLE ANTIBODY TSH I-125 RADIOIMMUNO Corning Medical & Scientific JLW Class II 1983-01-05
K823490 ORTHO BI-LEVEL ASSAYED LIPID PROFILE Ortho Diagnostic Systems, Inc. JJY Class I 1983-01-05
K823500 CHOLESTEROL REAGENT Ac Biochemical Laboratories, Inc. CHH Class I 1982-12-30
K822944 GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT Travenol Laboratories, S.A. CEW Class II 1982-12-30
K823474 ENZYMATIC GLUCOSE DETERMINATION The Dow Chemical Co. CGA Class II 1982-12-30
K822219 HUMAN PLASMA CONTROL FOR CEA-ROCHE Hoffmann-La Roche, Inc. JJX Class I 1982-12-28
K823445 ALKPHOR SYSTEM California Immuno Diagnostic, Inc. CIN Class II 1982-12-28
K823292 IMMOPHASE TM HPL RADIOIMMUNOASSAY Corning Medical & Scientific JMF Class II 1982-12-28
K823472 ULTRA CHEM BAN-UV #65080 & 65081 Emd Chemicals, Inc. CDQ Class II 1982-12-28
K823476 GAMMADAB LH RADIO-KIT #CA-1508 Clinical Assays, Inc. CEP Class I 1982-12-28
K823462 SINGLE VIAL AMYLASE PNP TEST Boehringer Mannheim Corp. JFJ Class II 1982-12-28
K823570 CORNING 170 PH/BLOOD GAS ANALYZER Corning Medical & Scientific CHL Class II 1982-12-28
K823402 ULTRACHEM BUN-UV-GEM SAEC APPLI.#65080& Emd Chemicals, Inc. CDQ Class II 1982-12-26
K821983 TITAN GEL LDH ISOENZYME KIT Helena Laboratories CEX Class II 1982-12-22
K823304 RIASET PROLACTIN RIA KIT Immulok, Inc. CFT Class I 1982-12-22
K823380 125-I LH RADIOIMMUNOASSAY KIT Clinetics Corp. CEP Class I 1982-12-22
K823341 TRIGLYCERIDES REAGENT SET TAG-GK Sterling Biochemical, Inc. CDT Class I 1982-12-22
K823379 125-I FSH RADIOIMMUNOASSAY KIT Clinetics Corp. CGJ Class I 1982-12-22
K823354 ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE Emd Chemicals, Inc. CHH Class I 1982-12-22
K823313 IN VITRO GAMMACOAT B-HCG RADIO. TEST Clinical Assays, Inc. JHI Class II 1982-12-22
K822913 URIC ACID REAGENT Ac Biochemical Laboratories, Inc. KNK Class I 1982-12-20
K823364 COUNT-10 SYSTEM FOR STAND. URINALYSIS V-Tech, Inc. JQW Class I 1982-12-15
K823202 FREE & TOTAL ESTRIOL KIT Diagnostic Products Corp. CGI Class I 1982-12-15
K823005 BIO MAG FREE T4 RADIOIMMUNOASSAY KIT Bioclinical Group CEC Class II 1982-12-15
K822897 DSL 1700 Diagnostic Systems Laboratories, Inc. JHW Class II 1982-12-15
K823266 POSITIVE I.D. SYSTEM Abbott Laboratories JJQ Class I 1982-12-15
K823353 CARCINO-CEK Biologics Intl., Inc. JJX Class I 1982-12-14
K823265 MONOCLONAL ANTIBODY T4 RADIO-KIT Bd Becton Dickinson Vacutainer Systems Preanalytic CDX Class II 1982-12-09
K822942 INNOTRON FLUORIMETER SERIES ONE-10 Innotron of Oregon, Inc. KHO Class I 1982-12-09
K823302 CHOLESTEROL CHOD-PAP TEST Boehringer Mannheim Corp. CHH Class I 1982-12-09
K822898 DSL 1600 Diagnostic Systems Laboratories, Inc. CIA Class II 1982-12-09
K823044 KM-KAL L3 Kmn Products, Inc. JIX Class II 1982-12-09
K823240 CAP-RIA 16 Capintec, Inc. JJJ Class I 1982-12-03
K823219 LIQUIZYME CALCIUM REAGENT SET American Research Products Co. CIC Class II 1982-12-03
K822778 BLOOD GAS EXPER. SYSTEM 8700 Exper Corp., Inc. JQP Class I 1982-12-03
K823201 HUMAN PLACENTAL LACTOGEN KIT Diagnostic Products Corp. JMF Class II 1982-11-29
K823170 LIQUIZYME TOTAL PROTEIN REAGENT Amresco, Inc. CEK Class II 1982-11-29

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