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Clinical Chemistry

13,051 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
KING DIAGNOSTICS CHOLESTEROL TEST (K811747)King Diagnostics, Inc.1981-07-10
TBG DIAGNOSTIC KIT (K811725)Immuno Assay Corp.1981-07-10
KING DIAGNOSTICS PHOSPHORUS TEST (K811749)King Diagnostics, Inc.1981-07-10
SELECT-A-FLOW (K811857)Wenmar Intl. Corp.1981-07-10
KING DIAGNOSTICS CALCIUM TEST (K811748)King Diagnostics, Inc.1981-07-10
BUN RATE REAGENT (K811193)Chem-Elec, Inc.1981-07-10
QUANTIMUNE ESTRIOL RIA (K811709)Bio-Rad1981-07-10
MRI PROLACTIN RIA KIT (K810949)Microanalytic Research, Inc.1981-07-10
IL #781, SEMI-AUTOMATED LOADER (K811696)Instrumentation Laboratory CO1981-07-01
LIQUIZYME SINGLE SOLUTION GLUCOSE REAG (K811592)Amresco, Inc.1981-07-01
HELENA FETAL-TEK 200 MARKER (K811695)Helena Laboratories1981-07-01
CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT (K811694)Baker Instructions Corp.1981-07-01
URIC ACID TEST (K811687)King Diagnostics, Inc.1981-07-01
CHLORIDE/CARBON DIOXIDE RATE REAGENT (K811701)Chem-Elec, Inc.1981-07-01
CREATININE REAGENT (K811659)Gilford Diagnostics1981-06-26
CARDIOZYME PLUS CK-MB ITEM #65045 (K811573)Harleco1981-06-25
TOTAL PROTEIN TEST (K811673)King Diagnostics, Inc.1981-06-25
CARDIOZYME PLUS CK-TOTAL ITEM #65046 (K811574)Harleco1981-06-25
HELENA FETAL-TEK 200 METHOD (K811588)Helena Laboratories1981-06-25
ACTH RADIOIMMUNOASSAY KIT (K811565)Immuno Nuclear Corp.1981-06-25
C-TERMINAL PTH BY RADIOIMMUNOASSAY KIT (K811566)Immuno Nuclear Corp.1981-06-25
CREATININE TEST (K811664)King Diagnostics, Inc.1981-06-25
CARDIOZYME PLUS CK-MB ITEM #65045 (G) (K811575)Harleco1981-06-25
ALBUMIN TEST (K811662)King Diagnostics, Inc.1981-06-25
CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A) (K811576)Harleco1981-06-25
POTASSIUM TEST (K811661)King Diagnostics, Inc.1981-06-25
N-TERMINAL HPTH BY RIA (K811418)Immuno Nuclear Corp.1981-06-24
REAGENT SET TRIGLYCERIDES (K811553)Boehringer Mannheim Corp.1981-06-18
TSH-P.E.G. (K811558)Nuclear Diagnostics, Inc.1981-06-18
FLEXIGRAM AUTO LOADER SYSTEM (K811525)Electro-Nucleonics Laboratories, Inc.1981-06-18
DIRECT TESTOSTERONE RIA (K811536)Immuchem Corp.1981-06-18
AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM (K811466)Ortho Diagnostic Systems, Inc.1981-06-12
IMIPRAMINE/DISIPRAMINE/LITHIUM (K811465)Ortho Diagnostic Systems, Inc.1981-06-12
DOXEPIN/DESMETHLDOXEPIN/LITHIUM (K811467)Ortho Diagnostic Systems, Inc.1981-06-12
ESTRIOL KIT (K811380)Cambridge Nuclear Corp.1981-06-09
WAKO URIC ACID B TEST (K811504)Wako Chemicals USA, Inc.1981-06-09
VENTRE/SEP (K811423)Ventrex Laboratories, Inc.1981-06-09
TECHNICON STAR SYSTEM (K811431)Technicon Instruments Corp.1981-06-09
T3 (RIA) KIT (K811213)Immuno Assay Corp.1981-05-29
NATAL-TEC HPL (K811370)Armkel, LLC1981-05-29
NATAL-TEC PROGESTERONE (K811369)Armkel, LLC1981-05-29
TOX TM ANALYZER (K811263)Abbott Laboratories1981-05-29
AMES SERA-PAK GLUCOSE REAGENT (K811392)Miles Laboratories, Inc.1981-05-29
EARLY PREGNANCY DETECTION (K811398)Immuchem Corp.1981-05-29
CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT (K810853)The Upjohn Co.1981-05-29
NATAL-TEC ESTRIOL (K811371)Armkel, LLC1981-05-29
COAT-A-COUNT T4 RIA KIT (K811315)Diagnostic Products Corp.1981-05-27
ULTRACHEM GLUC-DH, ITEM NO. 65048 (K811202)Harleco1981-05-27
PROSTATIC ACID PHOSPHATASE RADIOIMM. KIT (K811274)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-05-27
LIQUID CHROMATOGRAPHY COLUMNS (K811304)Supelco, Inc.1981-05-27
CORNING 965 CARBON DIOXIDE ANALYZER (K811257)Corning Medical & Scientific1981-05-27
GASTRIN RADIOIMMUNOASSAY TEST (K810722)Clinical Assays, Inc.1981-05-27
CYCLIC AMP RADIOIMMUNOASSAY KIT [125I] (K811273)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-05-27
HITACHI 705 AUTOMATIC BLOOD CHEMISTRY (K811194)Boehringer Mannheim Corp.1981-05-27
NOVA 5 (K811289)Nova Biomedical Corp.1981-05-27
INORGANIC PHOSPHORUS REAGENTS (K811222)Connecticut Diagnostics, Ltd.1981-05-21
TECHNICON SMAC II SYSTEM & ACCESSORIES (K811249)Technicon Instruments Corp.1981-05-21
KOVA STRIP 6 (K811219)Icl Scientific1981-05-21
HUMAN IGG-ALBUMIN TEST KIT (K811178)Meloy Laboratories, Inc.1981-05-15
ARIA II INSULIN RIA (K811144)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-05-15
MULTIANALYTE CONTROLS, ALL KINDS (K811182)Fisher Scientific Co., LLC1981-05-15
OSMOMETER MODEL OM-6010 (K811179)Fiske Med Science1981-05-15
PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT (K811169)Amersham Corp.1981-05-15
URINE PREGNANCY TEST STANDARD/CONTR. PK (K811150)Mallinckrodt Critical Care1981-05-15
QUANTA PHASE VITAMIN B-12/FOLATE RAD (K811177)Bio-Rad1981-05-15
HCG RADIOIMMUNOASSAY (K811116)Hoffmann-La Roche, Inc.1981-05-13
PH/BLOOD GAS CONTROL (ABC) (K811143)Instrumentation Laboratory CO1981-05-13
PHADEBAS ISOAMYLASE TEST (K810584)Pharmacia, Inc.1981-05-13
AUTOMATIC ELISA READER (K811111)Artek Systems Corp.1981-05-08
LUTEINIZING HORMONE DIRECT RIA KIT 125/I (K811024)Immunalysis Corporation1981-05-08
NUTRIENT AGAR (K811138)Acumedia Manufacturers, Inc.1981-05-05
MICROERMA SYSTEM (K811001)Dynatech Corp.1981-05-01
GELMAN ELECTROPHORESIS CONTROL (K811100)Gelman Sciences, Inc.1981-05-01
GLUCOSCAN TEST STRIPS (K810993)Lifescan, Inc.1981-04-29
FILTER SAMPLER BLOOD SERUM FILTER (K811036)Glasrock Plastics, Inc.1981-04-29
LKB 4460 FLUORIMETER (K811019)Lkb Instruments, Inc.1981-04-29
125 I-T4 RIA TEST KIT (K811070)Intl. Immunoassay Laboratories, Inc.1981-04-29
GLUCOSE REAGENT-ENZYMATIC-COLOR 500 (K811074)Reagents Applications, Inc.1981-04-29
HELENA VMA-SMC COLUMN METHOD (K810992)Helena Laboratories1981-04-29
BCD-HPP41C INTERFACE (K810968)Dynatech Corp.1981-04-23
WORTHINGTON CK (NAC) REAGENT SET (K810997)Worthington Diagnostic Systems1981-04-23
IN-VITRO TBG RADIOIMMUNOASSAY TEST (K810967)Clinical Assays, Inc.1981-04-23
MASS SPECTROMETER-MEDSPECT II (K810938)Allied Healthcare Products, Inc.1981-04-23
DAC-CEL HCG (K810215)Burroughs Wellcome Co.1981-04-17
BIO SET TM SUBSTRATE CALIBRATORS (K810963)Boehringer Mannheim Corp.1981-04-17
BIO SET TM PHOSPHOROUS CALIBRATOR (K810964)Boehringer Mannheim Corp.1981-04-17
RADIOIMMUNOASSAY THYROID STIM. HORM. KIT (K810948)Endocrine-Metabolic Center1981-04-17
CHORIO-SHURE (K810936)Nuclear Medical Laboratories, Inc.1981-04-17
GOT ISOENZYME ASSAY EIKEN KIT (K802447)Syn-Kit, Inc.1981-04-17
DATA-ZYME TRIGLYCERIDE (K810965)Data Medical Associates, Inc.1981-04-17
GILUCOCHEK REFLECTANCE METER (K810665)Lifescan, Inc.1981-04-17
CORNING VITAMIN B12 FOLATE DEFIC. CONTR. (K810952)Corning Medical & Scientific1981-04-17
CREATINE KINASE MB ISOENZYME IMMUNO UV (K810861)The Dow Chemical Co.1981-04-14
KOVA TROL I HUMAN URINE (DRIED) (K810917)Icl Scientific1981-04-14
GEMENI CK-MB ISOENZYME ABNORMAL SERUM (K810870)Gemini, Inc.1981-04-14
COAT-A-COUNT CORTISOL RIA KIT (K810891)Diagnostic Products Corp.1981-04-14
ISOMUNE-CK (K810905)Hoffmann-La Roche, Inc.1981-04-14
TRI-LEVEL NDI CONTROL (K810906)Nuclear Diagnostics, Inc.1981-04-14
FOLLICLE STIMULATING HORMONE (FSH) (K810867)Pcl-Ria, Inc.1981-04-14
FOLLICLE STIMULATING HORMONE ANTISERUM (K810852)Pcl-Ria, Inc.1981-04-08
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