meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
60
Latest Decision
1980-05-14

Clearances · page 117 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K800921 NORDICLAB TESTOSTERONE RIA TEST Nordiclab Intl. CDZ Class I 1980-05-14
K801012 TRIGLYCERIDE REAGENT (COLOR) Gilford Diagnostics JGY Class I 1980-05-14
K801015 PREZAPAK L ARTERIAL BLOOD SAMPLING KIT Kimble-Terumo, Inc. GIM Class II 1980-05-14
K800996 HDL REAGENT Gilford Diagnostics LBR Class I 1980-05-14
K800710 FERRITIRON KIT CAT. #RP-1100 Ria Products, Inc. JQG Class I 1980-05-14
K800719 ENZYMATIC UREA NITROGEN REAGENT SET REVI Macomb Chemical Co. CDQ Class II 1980-05-08
K800914 NO-BOIL FOLATE KIT #RP-500 Ria Products, Inc. CGN Class II 1980-05-08
K800649 ENZYMATIC TRIGLYCERIDES REAFENT FOR SMAC Reagents Applications, Inc. CDT Class I 1980-05-08
K800910 GAL-PUT CONTROLS, NORMAL&DEFICIENT Sigma Chemical Co. JIX Class II 1980-04-29
K800868 FERRO-QUANT TM FE 59 TEST KIT Mallinckrodt Critical Care JQG Class I 1980-04-29
K800769 Y-GT TEST, Y-GLUTAMYL TRANSFERASE TEST Sclavo, Inc. JQB Class I 1980-04-24
K800813 DIAGNOSTIC PRODUCTS CORP. RIA CONTROL Diagnostic Products Corp. JJY Class I 1980-04-24
K800848 SERALYZER URIC ACID REAGENT STRIPS - Miles Laboratories, Inc. KNK Class I 1980-04-24
K800798 HUMAN THYROID STIM. HORMONE/ARIA II Bd Becton Dickinson Vacutainer Systems Preanalytic JLW Class II 1980-04-24
K800538 GAMMA STICK CORTISOL RIA KIT/STICK KIT Alpha Gamma Laboratory CGR Class II 1980-04-24
K800765 CENTRIFICHEM CHOLESTEROL Union Carbide Corp. CHH Class I 1980-04-24
K800774 RENCTK Sorin Biomedica, Fiat, USA, Inc. CIB Class II 1980-04-21
K800776 TESTOK-125 Sorin Biomedica, Fiat, USA, Inc. CDZ Class I 1980-04-21
K800770 SLAVO CHOLESTEROL STAND. DIAGNOSTIC KIT Sclavo, Inc. JIT Class II 1980-04-21
K800775 ALDOCTK-125 Sorin Biomedica, Fiat, USA, Inc. CJM Class II 1980-04-21
K800757 IL MODEL 1303 PH/BLOOD GAS ANALYZER Instrumentation Laboratory CO CHL Class II 1980-04-21
K800740 PROLACTIN RIA KIT Amersham Corp. CFT Class I 1980-04-16
K800708 CODE QAS.105 PROLACTIN CONTROL SERA Amersham Corp. JJX Class I 1980-04-16
K800606 MICROMEDIC AUTOMATIC DILUTER Micromedic Systems JQW Class I 1980-04-16
K800700 AMERLEX CORTISOL RIA KIT Amersham Corp. CGR Class II 1980-04-16
K800724 AMES LAB MANAGEMENT SYSTEM Miles Laboratories, Inc. JQP Class I 1980-04-16
K800693 STANBIO PROSTATIC ACID PHOSPHATASE TEST Stanbio Laboratory CKE Class II 1980-04-16
K800601 HYDRAGAMMA 16 Innotron of Oregon, Inc. JJJ Class I 1980-04-10
K800628 KODAK EKTACHEM CLINICAL CHEM. SLIDES Eastman Kodak Company JGS Class II 1980-04-10
K800604 CK ISOENZYME ELECTROPHORESIS CONTROL-I.D Beckman Instruments, Inc. JJT Class I 1980-04-10
K800616 BUN REAGENT KIT #88108 Hi Chem, Inc. CDS Class II 1980-04-10
K800641 CENTRIFI CHEM AST/SGOT Union Carbide Corp. CIT Class II 1980-04-10
K800586 NSI CARBON DIOXIDE REAGENT KIT Nobel Scientific Industries, Inc. JFL Class II 1980-04-04
K800594 VENTRE/SEP CORTISOL RIA Ventrex Laboratories, Inc. CGR Class II 1980-04-04
K800568 TRANSPHOR TM LD LACTATE DEHYDROGENASE Corning Medical & Scientific CFE Class II 1980-04-04
K800590 BUN KIT Nobel Scientific Industries, Inc. CDS Class II 1980-04-04
K800588 NSI CALIBRATOR SET Nobel Scientific Industries, Inc. JIS Class II 1980-04-04
K800589 GLUCOSE OXIDASE REAGENT Nobel Scientific Industries, Inc. CGA Class II 1980-04-04
K800524 SERALYZER REFLECTANCE PHOTOMETER/CALIB. Miles Laboratories, Inc. CIE Class II 1980-04-02
K800585 NSI CHLORIDE REAGENT KIT Nobel Scientific Industries, Inc. JFS Class II 1980-04-02
K800550 LIPASE DETERMINATION The Dow Chemical Co. CFG Class I 1980-04-02
K800584 NSI SODIUM/POTASSIUM KIT Nobel Scientific Industries, Inc. JGS Class II 1980-04-02
K800583 NSI CREATININE KIT Nobel Scientific Industries, Inc. CGX Class II 1980-04-02
K800572 KDA MICRO CHEMICAL ANALYZER American Monitor Corp. JJE Class I 1980-04-02
K800327 MAGNESIUM REAGENT Alta Diagnostics, Inc. JGJ Class I 1980-03-25
K800556 DIFFERENTIAL REFRACTIVE INDEX DETECTOR Hewlett-Packard Co. KIE Class I 1980-03-25
K800559 SERTROL PRODUCT # ACS ST 101 Analytical Control Systems, Inc. JJY Class I 1980-03-25
K800522 MICRO ELISA AUTO READER Dynatech Laboratories, Inc. JJQ Class I 1980-03-25
K800558 LIPID CONTROL PRODUCT # ACS LC 101 Analytical Control Systems, Inc. JJY Class I 1980-03-25
K800551 TRIGLYCERIDES TEST (500NM) Reagents Applications, Inc. JGY Class I 1980-03-25
K800523 MONEL 80&90 ULTRAVIOLET-VISIBLE SPEC. Varian Assoc., Inc. JJQ Class I 1980-03-20
K800453 PHOTOVOLT PVA 4M+2 ANALYZER Photovolt Corp. JJC Class I 1980-03-20
K800457 LIQUID-STAT LIQUID REAGENT Beckman Instruments, Inc. CHH Class I 1980-03-20
K800544 CORNING TRANSPHOR Corning Medical & Scientific JHX Class II 1980-03-20
K800529 CENTRIFICHEM BUN Union Carbide Corp. CDQ Class II 1980-03-20
K800384 SMAC SYSTEM, T4 METHOD Technicon Instruments Corp. KLI Class II 1980-03-19
K800381 REFRIG. CENTRIFUGE (DRUCKER MODEL) Coulter Electronics, Inc. JQC Class I 1980-03-19
K800516 DUPONT INSTRUMENTS MODEL 870 LIQ. CHROM. E.I. Dupont DE Nemours & Co., Inc. KIE Class I 1980-03-19
K800203 RIA PHASE T4 Boehringer Mannheim Corp. CDX Class II 1980-03-19
K800204 RIA PHASE TBG Boehringer Mannheim Corp. CEE Class II 1980-03-19
K800436 T3 SOLID PHASE RADIOIMMUNOASSAY KIT Bd Becton Dickinson Vacutainer Systems Preanalytic CDP Class II 1980-03-19
K800385 ANALYTE T4-THYROXINE Technicon Instruments Corp. CDX Class II 1980-03-19
K792647 AUTOSCAN 3 Cnr Labs JJQ Class I 1980-03-17
K800304 CENTRIFICHEM FILTER CALIBRATION SET Union Carbide Corp. JIW Class II 1980-03-12
K792349 SUSCEPTIBILITY DISK, CINOXACIN 100 MCG. Pfizer, Inc. JNT Class I 1980-03-12
K800374 AMERLEX T-3 RIA KIT Amersham Corp. CDP Class II 1980-03-12
K800388 NML 5000 AUTO. GAMMA SCINT. COUNTER Nuclear Medical Laboratories, Inc. JJJ Class I 1980-03-12
K800370 CK/LD ISOENZYME CONTROL PROD. #ACS CT101 Analytical Control Systems, Inc. JJY Class I 1980-03-12
K800341 BUN REAGENT Gilford Diagnostics CDQ Class II 1980-03-12
K800061 BOND ELUT COLUMNS Analytichem International, Inc. DJY Class I 1980-03-12
K800300 AMERLEX T-4 RIA KIT Amersham Corp. CDX Class II 1980-03-05
K800282 DATA MANAGEMENT SYSTEM IL MODEL 775 Instrumentation Laboratory CO JQP Class I 1980-03-05
K800301 SIGMA PROCEDURE & REAGENT SYSTEM #335-UV Sigma Chemical Co. CDT Class I 1980-03-05
K800297 SANDARE FAST 340 PHOSPHOROUS PROCEDURE Sandare Chemical Co., Inc. CEO Class I 1980-03-05
K800242 MICRO MEDICAL DATA SYSTEM II Micro/Tel., Inc. JQP Class I 1980-03-03
K800245 EMIT AUTO CORTISOL ASSAY Syva Co. CGR Class II 1980-03-03
K800206 ACA CHOLESEROL/HDL CHOLESTEROL CALIBRAT. E.I. Dupont DE Nemours & Co., Inc. JIS Class II 1980-03-03
K800289 LDC SPECTROMONITOR III Laboratory Data Control KIE Class I 1980-02-26
K800217 CHLORIDE REAGENT, CUP & CLEANER Fisher Scientific Co., LLC JFS Class II 1980-02-26
K800218 CARBON DIOXIDE CUP REAGENT & REF.RGT. Fisher Scientific Co., LLC JFL Class II 1980-02-26
K800271 COROMETRICS MEDICAL SYSTEMS 220 PH SYS. Transidyne General Corp. CHL Class II 1980-02-26
K800219 SERUM CREATININE; ALK. BUFFER & PICRIC Fisher Scientific Co., LLC CGX Class II 1980-02-26
K800216 SODIUM/POTASSIUM CONDITIONING REAGENT Fisher Scientific Co., LLC JGS Class II 1980-02-26
K800241 MICRO MEDICAL DATA SYSTEM Micro/Tel., Inc. JQP Class I 1980-02-26
K800220 CALIBRATOR NO. 1 & 2, & WASH SOLUTION Fisher Scientific Co., LLC JIT Class II 1980-02-26
K800046 LDC CHROMATOGRAPHY ACCESSORY MODULE B Laboratory Data Control KIE Class I 1980-02-25
K800224 RADIOMETER ACID BASE LABORATORY-ABL-3 The London Co. CHL Class II 1980-02-22
K800199 LINEAR ENZYMATIC CHOLESTEROL SYSTEM Simmler, Inc. CHH Class I 1980-02-21
K800200 LINEAR ENZYMATIC GLUCOSE SYSTEM Simmler, Inc. CGA Class II 1980-02-21
K800130 CENTRIFICHEM URIC ACID Union Carbide Corp. CDO Class I 1980-02-13
K800111 CO2 CONTENT American Monitor Corp. CIL Class II 1980-02-13
K800085 SYSTEM 203 CHEMISTRY ANALYZER Gilford Instrument Laboratories, Inc. JJE Class I 1980-02-13
K800129 CENTRIFICHEM CREATININE Union Carbide Corp. CEX Class II 1980-02-13
K800107 FOLLICLE STIMULATING HORMONE Radioimmunoassay, Inc. CGJ Class I 1980-02-13
K800187 EMC-M-175, THYROXINE - 100 TUBES Endocrine-Metabolic Center CDX Class II 1980-02-13
K800126 RSL (125 L) PROGESTERONE KIT Radioassay Systems Laboratories, Inc. JLS Class I 1980-02-13
K800188 EMC-M-180, T3 UPTAKE - 100 TUBES Endocrine-Metabolic Center KHQ Class II 1980-02-13
K800170 AMES RIALYZE - UPTAKE CHROM. TUBES Miles Laboratories, Inc. KHQ Class II 1980-02-13
K792460 CALBIOCHEM-BEHRING RIA-COUNT Calbiochem-Behring Corp. CDD Class II 1980-02-13
K800190 STANBIO DIRECT URIC ACID TEST SET #0770 Stanbio Laboratory CDH Class I 1980-02-13

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