meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
55
Latest Decision
1987-01-13

Clearances · page 85 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K864744 CREATINE PHOSPHOKINASE (CK) Tech-Co, Inc. CGS Class II 1987-01-13
K862565 CHEMTROL(TM) G.B.F. Industries, Inc. JJY Class I 1987-01-13
K864742 UREA NITROGEN(BUN), COLORIMETRIC METHOD Tech-Co, Inc. CDL Class II 1987-01-13
K864905 ALKALINE PHOSPHATASE Tech-Co, Inc. CJE Class II 1987-01-13
K863959 OHMEDA 6000 MULTI-GAS MONITOR Ohmeda Medical JJQ Class I 1987-01-12
K864285 TERUMO OVATION SPECTROPHOTOMETER Terumo Medical Corp. JJQ Class I 1987-01-09
K864373 CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION) Unipath , Ltd. LCX Class II 1987-01-09
K864974 GENERAL PURPOSE CENTRIFUGE Norfolk Scientific, Inc. JQC Class I 1987-01-09
K863999 VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 Leeco Diagnostics, Inc. LCX Class II 1987-01-09
K864267 SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY) Millipore Corp. DPM Class I 1987-01-09
K864966 ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE Diagnostics Biochem Canada, Inc. CGF Class I 1987-01-09
K864850 WAKO(TM) AUTOKIT GPT Wako Chemicals USA, Inc. CKA Class I 1987-01-09
K861202 TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS Nms Pharmaceuticals, Inc. JJY Class I 1987-01-09
K864741 CRESOLPHTHALEIN COMPLEXONE, CALCIUM Tech-Co, Inc. CIC Class II 1987-01-09
K864677 TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP Serono Diagnostics, Inc. JLW Class II 1987-01-07
K862055 CANWEST OVU-BLUE Canwest Medictex, Inc. CEP Class I 1987-01-06
K864706 RAICHEM(TM) AMMONIA REAGENT Reagents Applications, Inc. JIF Class I 1987-01-05
K864945 TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY Hybritech, Inc. JFH Class II 1987-01-05
K864224 ABBOTT SPECTRUM GLUCOSE REAGENT Abbott Laboratories CGA Class II 1987-01-05
K863069 MAGNESIOMETER J. D. Assoc. JGJ Class I 1986-12-31
K864939 BECKMAN DRI-STAT TRIGLYCERIDES-GPO REAGENT KIT Beckman Instruments, Inc. CDT Class I 1986-12-31
K864236 SYNCHRON CX3 Beckman Instruments, Inc. JJF Class I 1986-12-31
K864303 QKO (TM) AMYLASE B-HA Wako Chemicals USA, Inc. JFJ Class II 1986-12-31
K864713 CHLORIDE REAGENT Sigma Diagnostics, Inc. CHJ Class II 1986-12-31
K864906 ALANINE AMINO TRANSFERASE ALT/SGPT Tech-Co, Inc. CKA Class I 1986-12-31
K864634 AP1 COLORIMETER Awareness Technology, Inc. JJQ Class I 1986-12-31
K864715 EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93 Em Diagnostic Systems, Inc. CIX Class II 1986-12-31
K863841 TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE Hybritech, Inc. LCX Class II 1986-12-22
K864133 DSL-5300 TSH IMMUNORADIOMETRIC ASSAY (IRMA) KIT Diagnostic Systems Laboratories, Inc. JLW Class II 1986-12-18
K860645 ELECTROPHORESIS DATA CENTER (EDC) Helena Laboratories JQT Class I 1986-12-17
K864075 UBI MAGIWEL(TM) PROLACTIN QUANTATIVE United Biotech, Inc. CFT Class I 1986-12-16
K864341 IQ URIC ACID TEST Bd Becton Dickinson Vacutainer Systems Preanalytic KNK Class I 1986-12-16
K864079 UBI MAGIWEL(TM) TSH QUANTITATIVE United Biotech, Inc. JLW Class II 1986-12-16
K864302 WAKO(TM) GOT II - HA Wako Chemicals USA, Inc. CIT Class II 1986-12-16
K864335 WAKO GPT II - HA Wako Chemicals USA, Inc. CKA Class I 1986-12-16
K864319 TDX(R) II ANALYZER Abbott Laboratories JJQ Class I 1986-12-16
K864560 IQ T4 IMMUNOASSAY Bd Becton Dickinson Vacutainer Systems Preanalytic CDX Class II 1986-12-16
K864268 IQ TRIGLYCERIDES Bd Becton Dickinson Vacutainer Systems Preanalytic CDT Class I 1986-12-16
K864435 VISION(TM) AMYLASE Abbott Laboratories JFJ Class II 1986-12-16
K863832 NAPHTHYL PHOSPHATE, ACID PHOSPHATASE Pointe Scientific, Inc., JFH Class II 1986-12-16
K864134 DSL-4800 ACTIVE TM TSH EIA SYSTEM Diagnostic Systems Laboratories, Inc. JLW Class II 1986-12-16
K864132 CIBA CORNING MAGIC(R) LITE TU IMMUNOASSAY Ciba Corning Diagnostics Corp. KHQ Class II 1986-12-16
K863933 VIS-CUBE HCG (EIA) Leeco Diagnostics, Inc. JHI Class II 1986-12-15
K863079 CREATINKINETIC J. D. Assoc. CGX Class II 1986-12-12
K863053 ALT S.C.E. (GPT) J. D. Assoc. CKA Class I 1986-12-10
K863068 LDH S.C.E. J. D. Assoc. CFJ Class II 1986-12-10
K863907 MODIFIED SODIUM ELECTRODE Ionetics, Inc. JGS Class II 1986-12-10
K863112 PROTEINMETER J. D. Assoc. JGP Class II 1986-12-10
K863468 EXACTECH(TM) Travenol Laboratories, S.A. CGA Class II 1986-12-08
K860948 TRACKER SYSTEM Boehringer Mannheim Corp. CGA Class II 1986-12-08
K864082 REFLOTRON(R) ALT (GPT) Boehringer Mannheim Corp. CKD Class I 1986-12-04
K863980 U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST U. S. Diagnostics, Inc. CJE Class II 1986-12-04
K863066 TRANSFERMETER J. D. Assoc. JQF Class I 1986-12-04
K862806 URINE DIAGNOSTIC REAGENT STRIPS Amatech International, Inc. JJB Class I 1986-12-04
K853733 MED-PEN/MED-POINT Garid, Inc. CGA Class II 1986-12-04
K864081 U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST U. S. Diagnostics, Inc. CHH Class I 1986-12-04
K864231 U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST U. S. Diagnostics, Inc. CDT Class I 1986-12-04
K863928 TERUMO SENSIBEAD EIA FSH KIT Terumo Medical Corp. CGJ Class I 1986-12-04
K864230 DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM E.I. Dupont DE Nemours & Co., Inc. CKE Class II 1986-11-28
K863963 EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95 Em Diagnostic Systems, Inc. CIT Class II 1986-11-28
K864060 MICRO-READER Hyperion, Inc. JJQ Class I 1986-11-28
K863962 EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95 Em Diagnostic Systems, Inc. CKA Class I 1986-11-28
K863927 CHOLESTEROL Tech-Co, Inc. CHH Class I 1986-11-24
K863109 FERROFAST J. D. Assoc. JIY Class I 1986-11-24
K862958 AMR RESEARCH TONOMETER Associated Medical Representatives LCH Class I 1986-11-24
K863925 UREA NITROGEN(BUN) Tech-Co, Inc. CDQ Class II 1986-11-24
K863751 MULTI-ANALYTE LIN-TROL Sigma Diagnostics, Inc. JJY Class I 1986-11-24
K863056 BILIRUBIN TOTAL J. D. Assoc. CIG Class II 1986-11-24
K863889 UREA NITROGEN TEST U. S. Diagnostics, Inc. CDL Class II 1986-11-24
K864208 VISION (TM) GGTP Abbott Laboratories JPZ Class I 1986-11-24
K863901 IQ UREA NITROGEN Bd Becton Dickinson Vacutainer Systems Preanalytic JGZ Class II 1986-11-24
K863849 LIQUI-SERA COMBO LIGAND/TDM CONTROLS Biodiagnostic Intl JJY Class I 1986-11-24
K863923 TRIGLYCERIDES Tech-Co, Inc. CDT Class I 1986-11-24
K863924 URIC ACID Tech-Co, Inc. KNK Class I 1986-11-24
K863880 BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD. D.R.G. Scientific Industries CHL Class II 1986-11-24
K864144 LUTEINIZING HORMONE (LH-IRMA) RIA KIT Immuchem Corp. CEP Class I 1986-11-24
K864156 PROGESTERONE SYSTEM BY EIA Intl. Bioclinical, Inc. JLS Class I 1986-11-24
K863102 GLUCOMETER-E J. D. Assoc. CGA Class II 1986-11-24
K863860 TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN Hybritech, Inc. CFT Class I 1986-11-21
K863859 TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM Hybritech, Inc. JLW Class II 1986-11-21
K863861 TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA Hybritech, Inc. JHI Class II 1986-11-21
K863670 VISION (TM) CALCIUM Abbott Laboratories CIC Class II 1986-11-13
K852767 ERYTHOCYTE CREATINE Panmed, Inc. JLA Class I 1986-11-13
K864080 UBI MAGIWEL(TM) FSH QUANTITATIVE United Biotech, Inc. CGJ Class I 1986-11-13
K863874 LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES Electro-Nucleonics Laboratories, Inc. CDT Class I 1986-11-13
K863926 GLUCOSE OXIDASE Tech-Co, Inc. CGA Class II 1986-11-13
K863948 A-GENT(TM) LIQUID GLUCOSE TRINDER Abbott Laboratories CGA Class II 1986-11-13
K863929 TERUMO SENSIBEAD(TM) EIA HLH KIT Terumo Medical Corp. CEP Class I 1986-11-13
K863741 IMMUNO-CEPT D (BETA-MONOCLONAL) Immunostics Co., Inc. JHJ Class II 1986-11-13
K863719 AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1 Technicon Instruments Corp. CIJ Class II 1986-11-13
K862984 UNIDEX GLUCOSE TEST STRIP Unidex, Inc. CGA Class II 1986-11-05
K863887 SMI MULTIPETTOR(TM) American Dade JQW Class I 1986-11-05
K863744 HCG CONTROL KIT Monoclonal Antibodies, Inc. JJX Class I 1986-11-05
K861211 MONO ACU-SLIDE TEST Cal-Tech Diagnostics, Inc. JHJ Class II 1986-11-05
K863521 LYTENING 2 Amdev, Inc. JGS Class II 1986-11-05
K863802 VMAX KINETIC MICROPLATE READER Molecular Devices Corp. JJQ Class I 1986-11-05
K863840 METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM E.I. Dupont DE Nemours & Co., Inc. JJE Class I 1986-11-05
K863738 EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95 Em Diagnostic Systems, Inc. CGX Class II 1986-11-05
K863660 EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95 Em Diagnostic Systems, Inc. CDO Class I 1986-10-29
K861883 IMMUNOCHEMICAL ASSAY OF APOLIPOPROTEIN A1 Orion Corp. MSJ Class I 1986-10-29

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