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Clinical Chemistry

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

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RecordFirmDate
SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA (K860228)Boots-Celltech Diagnostics, Inc.1986-02-28
IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS (K854094)Immuchem Corp.1986-02-28
EASY-TEST UREA (BUN) REAGENT (K860135)Em Diagnostic Systems, Inc.1986-02-21
DIRECT BILIRUBIN (K860257)Pointe Scientific, Inc.,1986-02-21
RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR (K855108)Biomaterials International, Inc.1986-02-21
PHOTIC-100 SPECTROPHOTOMETER (K854679)Future Impex Corp.1986-02-20
URIC ACID REAGENT SET (K860111)Technostics Intl.1986-02-19
ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040 (K860453)Sigma Diagnostics, Inc.1986-02-19
SERUM ALBUMIN (BCG) REAGENT SET (K860340)Sterling Diagnostics, Inc.1986-02-19
TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT (K860130)Cambridge Medical Technology1986-02-19
PARAMAX COMPREHENSIVE CALIBRATOR (K855199)American Dade1986-02-19
ENZYNATIC TRIGLYCERIDES REAGENT SET (K855164)Sterling Diagnostics, Inc.1986-02-19
MAGNESIUM REAGENT SET (K855190)Technostics Intl.1986-02-18
TERUMO SENSIBEAD EIG HCG KIT (K854670)Terumo Medical Corp.1986-02-13
QWIKSPIN (TM) (K860172)Norfolk Scientific, Inc.1986-02-11
UREA NITROGEN REAGENT SET (K860419)Sterling Diagnostics, Inc.1986-02-11
EMDS GLUCOSE TEST PACK ITEM 67656/95 (K855080)Em Diagnostic Systems, Inc.1986-02-11
CALCIUM (CPC) REAGENT SET (K860044)Sterling Diagnostics, Inc.1986-02-11
COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER (K855149)Hyperion, Inc.1986-02-11
ALKALINE PHOSPHATASE REAGENT SET (K860351)Sterling Diagnostics, Inc.1986-02-11
URIC ACID REAGENT SET (COLORIMETRIC) (K860142)Sterling Diagnostics, Inc.1986-02-11
DIMENSION(TM) CLINICAL CHEMISTRY SYSTEM (K860021)E.I. Dupont DE Nemours & Co., Inc.1986-02-11
MAGNESIUM REAGENT SET (K860215)Sterling Diagnostics, Inc.1986-02-11
GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET (K860110)Technostics Intl.1986-02-11
TOTAL PROTEIN (BIURET) REAGENT SET (K860341)Sterling Diagnostics, Inc.1986-02-11
ALBUMIN REAGENT KIT (K860213)Bio-Analytics Laboratories, Inc.1986-02-11
MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY (K854945)Ciba Corning Diagnostics Corp.1986-02-11
CPK REAGENT SET (COLORIMETRIC) (K860096)Sterling Diagnostics, Inc.1986-02-11
CREATININE REAGENT SET (K860418)Sterling Diagnostics, Inc.1986-02-11
AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA (K860252)Amersham Corp.1986-02-11
AMERLEX-M T4 RIA KIT FOR SERUM AND PLASMA (K860251)Amersham Corp.1986-02-11
STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY (K860421)American Dade1986-02-11
TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500 (K854406)Tecan U.S., Ltd.1986-02-10
URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE (K860143)Reagent Laboratory, Inc.1986-02-10
T3 UPTAKE RADIOIMMUNOASSAY KIT (K855169)Cambridge Medical Technology1986-02-06
LDH (OPTIMIZED) REAGENT (K860029)Sigma Chemical Co.1986-02-06
EIA PROCESSOR (K854936)Abbott Laboratories1986-02-06
BUN (ENZYMATIC BERTHELOT) REAGENT SET (K860154)Sterling Diagnostics, Inc.1986-02-06
EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT (K860134)Em Diagnostic Systems, Inc.1986-02-06
V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT (K854971)V-Tech, Inc.1986-02-06
ENZYMATIC UREA NITROGEN REAGENT SET (K860109)Technostics Intl.1986-02-06
HCG RIA TEST SYSTEM (K854958)Monobind1986-01-28
TOTAL CHOLESTEROL REAGENT SET (K855028)Sterling Diagnostics, Inc.1986-01-28
DSL ANDROSTENEDIONE RIA (DSL #4200) (K854675)Diagnostic Systems Laboratories, Inc.1986-01-28
ALLEGRO PROLACTIN IMMUNOASSAY SYSTEM (K854805)Nichols Institute Diagnostics1986-01-28
T-3 UPTAKE/RIASSAY (K855033)Ria Diagnostics1986-01-24
OLYMPUS AU 5000 CHEMISTRY ANALYZER SYSTEM (K860080)Olympus Corp.1986-01-24
TOTAL LIPIDS REAGENT SET (K860112)Technostics Intl.1986-01-24
SERALYZER TOTAL BILIRUBIN CALIBRATORS (K855040)Miles Laboratories, Inc.1986-01-22
SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV (K854245)Sigma Diagnostics, Inc.1986-01-22
DSL ANDROSTENEDIONE RIA (DSL # 4200) (K854673)Diagnostic Systems Laboratories, Inc.1986-01-22
TRIGLYCERIDE'S TEST (TRIGLI-CINET) (K854783)Sclavo, Inc.1986-01-22
CALCIUM LIQUID STABLE REAGENT SET (K855041)Medical Analysis Systems, Inc.1986-01-22
GLUCOSE REAGENT SET (K855185)Technostics Intl.1986-01-22
EMDS TOTAL CK TEST PACK-#67670/95 (K855056)Em Diagnostic Systems, Inc.1986-01-22
CLEANING REAGENT KIT PRODUCT NO 88194 (K855196)Hi Chem, Inc.1986-01-22
LACTIC DEHYDROGENASE (VV) REAGENT SET (K855157)Technostics Intl.1986-01-21
TDXR 5-HIAA (URINE) (K854946)Abbott Laboratories1986-01-17
CREATININE PAP (K854766)Boehringer Mannheim Corp.1986-01-17
CANTROL CK/MB CONTROL (K855006)Canyon Diagnostics, Inc.1986-01-17
ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL (K855225)Boehringer Mannheim Corp.1986-01-17
CANTROL ELECTROPHORESIS CONTROL (K854931)Canyon Diagnostics, Inc.1986-01-17
KODAK EKTACHEM HDL CHOLESTEROL KIT (K854426)Eastman Kodak Company1986-01-17
T-4 RIASSAY (K854798)Ria Diagnostics1986-01-15
NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928 (K854717)Nobel Scientific Industries, Inc.1986-01-14
VISION SGOT (AST) (K854982)Abbott Laboratories1986-01-14
LACTIC DEHYDROGENASE REAGENT SET (K855159)Technostics Intl.1986-01-14
ALBUMIN REAGENT SET (K855158)Technostics Intl.1986-01-14
DIRECT & TOTAL BILIRUBIN SET (K855195)Technostics Intl.1986-01-14
CREATININE REAGENT SET (K855193)Technostics Intl.1986-01-14
GLUCOSE OXIDASE REAGENT SET (K855194)Technostics Intl.1986-01-14
ENZYMATIC CHOLESTROL REAGENT SET (K855187)Technostics Intl.1986-01-14
GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET (K855186)Technostics Intl.1986-01-14
INORGANIC PHOSPHORUS REAGENT SET (K855154)Technostics Intl.1986-01-14
GLUCOSE (UV HEXOKIASE) REAGENT SET (K855153)Technostics Intl.1986-01-14
ALKALINE PHOSPHATASE REAGENT SET (K855192)Technostics Intl.1986-01-14
GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET (K855189)Technostics Intl.1986-01-14
GAMMA GLUTAMYL TRANSPEPTIDASE REAGENT SET (K855156)Technostics Intl.1986-01-14
TOTAL PROTEIN REAGENT SET (K855191)Technostics Intl.1986-01-14
TERUMO SENSIBEAD EIA HPRL KIT (K854768)Terumo Medical Corp.1986-01-13
LEE-BEAD BETA FSH (EIA) (K854837)Leeco Diagnostics, Inc.1986-01-13
CANWEST-PREGBLUE (K854989)Canwest Medictex, Inc.1986-01-13
V-TREND OC CPK (K854973)V-Tech, Inc.1986-01-13
VISION CREATININE (K854846)Abbott Laboratories1986-01-13
MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO (K854059)Bioclinical Systems, Inc.1986-01-13
RANGE-CHEK (K854789)American Monitor Corp.1986-01-13
ANALYST PHYSICIAN'S OFFICE PROFILER (K854523)E.I. Dupont DE Nemours & Co., Inc.1986-01-08
MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT (K854379)Bioclinical Systems, Inc.1986-01-07
ISOTRAK AMYLASE TEST AMYLASE ISOENZYME (K853951)Behring Diagnostics, Inc.1986-01-07
NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909 (K854716)Nobel Scientific Industries, Inc.1986-01-07
LEE-BEAD BETA LH (EIA) (K854838)Leeco Diagnostics, Inc.1986-01-07
CRITIC - SF, ASSAYED (K854967)Dimension Diagnostics1986-01-07
ASSERACHROM PROTEIN C KIT (K854016)American Bioproducts Co.1986-01-03
DART CK-MB REAGENT SYSTEM (K854708)Coulter Electronics, Inc.1985-12-30
RAMP URINE HCG ASSAY (K854611)Monoclonal Antibodies, Inc.1985-12-30
IN VITRO TEST DETERMINATION OF SGPT(ALT) (K854186)Clinical Data, Inc.1985-12-25
CRITIC C LEVEL I & II (K853943)Dimension Diagnostics1985-12-23
NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926 (K854718)Nobel Scientific Industries, Inc.1985-12-19
QUANTTEST TOTAL PROTEIN ASSAY (K853932)Quantimetrix Corp.1985-12-19
DSL ACTIVE TESTOSTERONE RIA (DSL #4000) (K854671)Diagnostic Systems Laboratories, Inc.1985-12-19
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