meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
61
Latest Decision
1978-10-27

Clearances · page 123 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K781690 L-CYSTEINE HYDROCHLORIDE Fisher Scientific Co., LLC JHS Class II 1978-10-27
K781629 SERI-SEP SERUM/PLASMA ISLOLATOR Wako Intl., Inc. JKA Class II 1978-10-27
K781646 SRD-2 Dynatech Laboratories, Inc. JQW Class I 1978-10-27
K781645 AUTODILUTER 2 Dynatech Laboratories, Inc. JQW Class I 1978-10-27
K781611 CHOLESTEROL DET. IN SERUM Fisher Scientific Co., LLC CGO Class I 1978-10-24
K781609 ALKALINE PHOSPHATASE IN SERUM Fisher Scientific Co., LLC CJE Class II 1978-10-24
K781610 BILIRUBIN DETERMINTAITON IN SERUM Fisher Scientific Co., LLC CIG Class II 1978-10-24
K781593 RIA CONTROLS Dade, Baxter Travenol Diagnostics, Inc. JJY Class I 1978-10-17
K781599 I-ESTRIOL TEST SET Wien Laboratories, Inc. CGI Class I 1978-10-17
K781560 RIA DIAG. TEST KIT FOR INDEXING THYROX. Nuclear Diagnostics, Inc. CEC Class II 1978-10-17
K781487 EARLY PREGNANCY DETECTION KIT Radioassay Systems Laboratories, Inc. JHI Class II 1978-10-11
K781554 RAD-291 Organon, Inc. JQX Class I 1978-10-11
K781441 BCG ALBUMIN REAGET Analytical & Research Chemicals, Inc. CIX Class II 1978-10-10
K781460 CHLORIDE REAGENT Analytical & Research Chemicals, Inc. CHJ Class II 1978-10-10
K781578 RIA QUANT B-HCG TEST KIT Mallinckrodt Critical Care JHI Class II 1978-10-10
K781501 ENZAC INCUBATOR Bd Becton Dickinson Vacutainer Systems Preanalytic JRG Class I 1978-10-03
K781544 EPPENDORF PCP 6121 Marilyn L. Amick JJQ Class I 1978-10-03
K781538 SINGLE VIAL LDH-L TRIS Boehringer Mannheim Corp. CFJ Class II 1978-10-03
K781644 ANTIBIOTIC NEPHELOMETER Biovation, Inc. JQX Class I 1978-10-03
K781576 MINI-KEM Coulter Electronics, Inc. JJQ Class I 1978-10-03
K781635 CHLORIDE TEST SET, CAT.# 0210 Stanbio Laboratory CHJ Class II 1978-10-03
K781466 AUTOMATED ENZYMATIC TRIGLYCERIDE REAGENT Fisher Scientific Co., LLC CDT Class I 1978-10-03
K781432 STAT ULTRA VIOLET LIQUID Beckman Instruments, Inc. JHS Class II 1978-10-03
K781477 TRIGLYCERIDES TEST KIT Mallinckrodt Critical Care CDT Class I 1978-10-03
K781533 SMA/GGT Technicon Instruments Corp. JPZ Class I 1978-10-03
K781489 ACID PHOSPHATASE DIAG. KIT Sclavo, Inc. CJN Class II 1978-10-03
K781442 BECKMAN ASTRA SYSTEM Beckman Instruments, Inc. JJF Class I 1978-10-03
K781606 MEPA-1 BLOOD ANALYZER Medico Electronic, Inc. JJF Class I 1978-10-03
K781472 MITROPHENYL, ALKALINE PHOSPHATES Beckman Instruments, Inc. CJE Class II 1978-09-27
K781409 IMMO PHASE, THYROID HORMONE Corning Medical & Scientific JLW Class II 1978-09-27
K781483 ORTHO*T-4 RIA (PEG) KIT Ortho Diagnostics, Inc. CDX Class II 1978-09-27
K781528 COULTER ELECTROLYTE ANALYZER SYSTEM Coulter Electronics, Inc. JJE Class I 1978-09-27
K781481 ORTHO*T-3 RIA (PEG) KIT Ortho Diagnostics, Inc. CDP Class II 1978-09-27
K781081 EMIT MCA PROGRAM TAPE Instrumentation Laboratory CO JQP Class I 1978-09-27
K781503 TECHNICON STAT/LYTE ISE ELECTROLYTE Technicon Instruments Corp. JJC Class I 1978-09-27
K781482 ORTHO*T-3 UPTAKE KIT Ortho Diagnostics, Inc. KHQ Class II 1978-09-27
K781410 RIALYZE VITAMIN B-12 TEST Ames Div., Miles Laboratories, Inc. CDD Class II 1978-09-27
K781454 LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA Union Carbide Corp. CHW Class II 1978-09-20
K781417 PRECISION GAS MIXER Medicor USA , Ltd. LCH Class I 1978-09-20
K781421 BIOSCAN E12 Clinifax Industries, Ltd. JJS Class I 1978-09-20
K781043 CEA-IMMERSIBLE SEPARATOR Millipore Corp. JRL Class I 1978-09-15
K781396 CREATININE REAGENT SET Nobel Scientific Industries, Inc. CGX Class II 1978-09-14
K781173 COMPUTER INTERFACE IL 814 Instrumentation Laboratory CO JQP Class I 1978-09-14
K781386 EBS 775 TONOMETER Equilibrated Bio Systems, Inc. LCH Class I 1978-09-14
K781379 MODEL 5000, LIQUID CHROMATOGRAPHY Varian Assoc., Inc. KIE Class I 1978-09-14
K780886 SYSTEM 6000 AUTOMATED RIA ANALYZER Beckman Instruments, Inc. LCI Class I 1978-09-01
K781284 RABBIT ANTIBODY TO HUMAN T3 Pcl-Ria, Inc. CDP Class II 1978-08-31
K781305 UREA NITROGEN Analytical & Research Chemicals, Inc. CDW Class II 1978-08-31
K781308 GLUCOLOUR Analytical & Research Chemicals, Inc. CGE Class II 1978-08-31
K781342 GLUCOSE TEST Wako Intl., Inc. CGA Class II 1978-08-31
K781307 GLUCOSE DETERM. KIT Analytical & Research Chemicals, Inc. CGA Class II 1978-08-31
K781275 CHLORIDE/CARBON DIOXIDE REAGENT SET Nobel Scientific Industries, Inc. JFS Class II 1978-08-31
K781310 HUMAN CHORIONIC GONADO.-BETA RIA KIT Diagnostics Biochem Canada, Inc. JHI Class II 1978-08-31
K781324 ALP TEST Analytical & Research Chemicals, Inc. CIO Class II 1978-08-31
K781225 GLOBULIN TEST, HUMAN THYROXINE BINDING Hyland Therapeutic Div., Travenol Laboratories CEE Class II 1978-08-31
K781296 THYRO-SHURE Nuclear Medical Laboratories, Inc. JLW Class II 1978-08-31
K781306 UREA NITROGEN TEST KIT Analytical & Research Chemicals, Inc. CDL Class II 1978-08-31
K781423 DUAL COMPONENT STANDARDS Abbott Laboratories JIT Class II 1978-08-31
K781253 BUN (UREASE) REAGENT Coulter Electronics, Inc. CDN Class II 1978-08-21
K781217 DATA TERMINAL MODEL 722 Corning Medical & Scientific JQP Class I 1978-08-21
K781240 ENZYMATIC TRIGLYCERIDES REAGENT KIT J.T. Baker Chemical Co. CDT Class I 1978-08-17
K781086 INSULIN AUTOPAK Micromedic Systems CFP Class I 1978-08-14
K781170 QUANTIMUNE HTSH IRMA HUMAN THYROID Bio-Rad JLW Class II 1978-08-14
K781182 MICRO THYROXINE REAGENT SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic CDX Class II 1978-08-14
K781071 STANDARDS, HORMONE, THYROID STIMULATING Pcl-Ria, Inc. JIT Class II 1978-08-14
K781100 DELTA TEST AMYLASE/LIPASE CONTS. I,II Bd Becton Dickinson Vacutainer Systems Preanalytic JJT Class I 1978-08-14
K781149 CPK-L TUBE Bd Becton Dickinson Vacutainer Systems Preanalytic CGS Class II 1978-08-14
K780972 QUICKRATE REACTION RATE ANALYZER Olympus Corp. JJI Class I 1978-08-14
K781093 HDL CENTRIFIKIT Beckman Instruments, Inc. LBR Class I 1978-08-14
K781138 SPECTROPHOTOMETER Bausch & Lomb, Inc. JJQ Class I 1978-08-14
K781076 CHEMISTRY ANALYZER Johns Scientific, Inc. JJE Class I 1978-08-14
K781241 UNISTAT BILIRUBINOMETER American Optical Corp. JJQ Class I 1978-08-14
K781180 CLINIRIA T-3 UPTAKE TEST Miles Laboratories, Inc. KHQ Class II 1978-08-14
K781181 CLINIRIA TOTAL T-4 (RIA) TEST Miles Laboratories, Inc. CDX Class II 1978-08-14
K781075 STATTEK-GLUCOSE LOW LEVEL Boehringer Mannheim Corp. CGA Class II 1978-08-14
K781285 INSULIN RIA KIT Serono Laboratories, Inc. CFP Class I 1978-08-14
K781069 T3 STANDARDS IN HUMAN SERUM Pcl-Ria, Inc. JIT Class II 1978-08-14
K781235 IV VITRO GAMMADAB T4 RIA KIT Clinical Assays, Inc. CDX Class II 1978-08-14
K781337 CONJUGATED BILE ACIDS RIA KIT Bd Becton Dickinson Vacutainer Systems Preanalytic KWW Class II 1978-08-11
K781120 TRICHLORACETIC ACID 7.5% Electrophoresis Corp. of America CEF Class I 1978-08-10
K781117 ECA PREP Electrophoresis Corp. of America CEF Class I 1978-08-10
K781128 LDH (UV KINETIC) Macomb Chemical Co. CFJ Class II 1978-08-10
K781125 LDH ISOENZYME REAGENT Electrophoresis Corp. of America CFE Class II 1978-08-10
K781132 CHEMLAR Hi Chem, Inc. JFS Class II 1978-08-10
K781118 ECA BUFFER PH 8.8 Electrophoresis Corp. of America CEF Class I 1978-08-10
K781124 CPK ISOENZYME REAGENT Electrophoresis Corp. of America JHW Class II 1978-08-10
K781116 ECA BUFFER, PH 816 Electrophoresis Corp. of America CEF Class I 1978-08-10
K781123 PONCEAU S Electrophoresis Corp. of America CEF Class I 1978-08-10
K781072 TRAP-BLOOD VESSEL STABILIZATION DEVICE Ayer, Patrick, M.D. JIT Class II 1978-08-10
K781013 ENZYMATIC REAGENT FOR CHOLESTEROL MEAS Coulter Electronics, Inc. CHH Class I 1978-07-28
K780943 BUN TEST UNI-UV BLOOD UREA NITROGEN TEST Sclavo, Inc. CDQ Class II 1978-07-27
K780983 CALCIUM REAGENT SYSTEM NO. 585 Sigma Chemical Co. CIC Class II 1978-07-27
K781004 HMA URIC ACID TEST Hycel, Inc. KNK Class I 1978-07-27
K780944 LIQUID CHROMATOGRAPH MODEL 850 E.I. Dupont DE Nemours & Co., Inc. KZR Class I 1978-07-27
K780854 IN VITRO NEONATAL T4 Clinical Assays, Inc. CDX Class II 1978-07-27
K781012 RIA TEST KIT SYS. DAMON KIQUISOL FREE Damon Corp. CEC Class II 1978-07-27
K780859 PRINCETON BIOMEDIX URICASE (UV) Bd Becton Dickinson Vacutainer Systems Preanalytic CDO Class I 1978-07-27
K780945 LIQUID CHROMATOGRAPH MODEL 860 E.I. Dupont DE Nemours & Co., Inc. KZR Class I 1978-07-27
K780933 PREP I AUTOMATED SAMPLE PROCESSOR E.I. Dupont DE Nemours & Co., Inc. LDM Class I 1978-07-27
K780455 QUANTITATIVE DETERMINATION OF PORPHYRINS Whale Scientific, Inc. JKJ Class I 1978-07-27

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