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Smithkline Diagnostics, Inc.

42 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
FLEXSURE OBT (K961062)Smithkline Diagnostics, Inc.1996-11-06
FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS) (K960183)Smithkline Diagnostics, Inc.1996-06-07
FLEXSURE HP (K934863)Smithkline Diagnostics, Inc.1994-05-18
HEMOCCULT SENSITIVE TEST (K880499)Smithkline Diagnostics, Inc.1988-05-23
(SKD) CHOLESTEROL TEST KIT (K875131)Smithkline Diagnostics, Inc.1988-03-01
HEMOCCULT WIPE TEST (K862849)Smithkline Diagnostics, Inc.1986-12-09
SKD ELECTROCHEMICAL SYSTEM (ECS) (K854723)Smithkline Diagnostics, Inc.1986-03-05
RAPID DIRECT STREP A LATEX AGGLUTINATION TEST (K852841)Smithkline Diagnostics, Inc.1985-07-24
GASTROCCULT TM (K821884)Smithkline Diagnostics, Inc.1982-10-08
SPINCHEM ACID PHOSPHATASE REAGENT (K821674)Smithkline Diagnostics, Inc.1982-06-22
SPIN CHEM REAGENTS & STANDARDS (K821184)Smithkline Diagnostics, Inc.1982-05-24
TARGET ISOCHECK CONTROL SERUM (K821183)Smithkline Diagnostics, Inc.1982-05-14
SKI 5000 (K812646)Smithkline Diagnostics, Inc.1981-11-16
SPIN-CHEM LD-L REAGENT (K812472)Smithkline Diagnostics, Inc.1981-09-14
SPIN-CHEM TRIGLYCERIDES REAGENT (K812471)Smithkline Diagnostics, Inc.1981-09-14
ESKAFLOW TEST FOR TRIGLYCERIDES (K811850)Smithkline Diagnostics, Inc.1981-07-23
ESKAFLOW TEST FOR GLUCOSE (K811849)Smithkline Diagnostics, Inc.1981-07-15
5CM SMALL PARTS SCANNER (K810914)Smithkline Diagnostics, Inc.1981-05-08
ESKACHEM PAP REAGENT (K803234)Smithkline Diagnostics, Inc.1981-02-26
HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE (K801060)Smithkline Diagnostics, Inc.1980-06-04
MODEL SKI-200 ABDOMINAL SCANNER (K800824)Smithkline Diagnostics, Inc.1980-05-14
S.K. DIAG. ULTRASND. SMALL PARTS SCAN (K800531)Smithkline Diagnostics, Inc.1980-04-10
S.K. DIAG. ULTRASOUND BODY SCANNER (K800532)Smithkline Diagnostics, Inc.1980-04-10
ESKACHEM, CK-MB REAGENT (K792023)Smithkline Diagnostics, Inc.1979-10-30
PLUS CHEM S.C.E. REAGENT (K791080)Smithkline Diagnostics, Inc.1979-07-24
SPIN CHEM, DETERMINATION OF ALT (GPT) (K791083)Smithkline Diagnostics, Inc.1979-07-17
PLUS CHEM, DETERMINATION OF ALT (GPT) (K791084)Smithkline Diagnostics, Inc.1979-07-17
SPIN CHEM REAGENT, DETERMINATION OF AST (K791082)Smithkline Diagnostics, Inc.1979-07-17
SPIN CHEM REAGENT, DETERMINATION OF LDH- (K791081)Smithkline Diagnostics, Inc.1979-07-17
PLUS CHEM, DETERMINATION OF LD (LDH-P) (K791085)Smithkline Diagnostics, Inc.1979-07-17
SPIN CHEM CK-NAC REAGENT (K790917)Smithkline Diagnostics, Inc.1979-06-22
ESKLAB REAGENT TABLETS (K790918)Smithkline Diagnostics, Inc.1979-06-22
CK-NUC REAGENT (K790916)Smithkline Diagnostics, Inc.1979-06-22
ASPIRATOR & PROBE, CYTOLOGY, ENDOMET. (K772121)Smithkline Diagnostics, Inc.1977-11-17
IN VITRO DIAG. FOR URIC ACID (K770767)Smithkline Diagnostics, Inc.1977-07-05
CHOLESTEROL REAGENT (K770483)Smithkline Diagnostics, Inc.1977-06-08
SIGMOIDOSCOPE/ DISPOSABLE (K761180)Smithkline Diagnostics, Inc.1977-01-05
REAL TIME OBSTETRICAL ULTRASONIC SCANNER (K761052)Smithkline Diagnostics, Inc.1976-12-16
EKOSECTOR I (K761030)Smithkline Diagnostics, Inc.1976-12-13
TEST, RIA, TRIODOTHYRONINE (K760057)Smithkline Diagnostics, Inc.1976-09-13
REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER (K760055)Smithkline Diagnostics, Inc.1976-08-26
TEST, RIA, SERUM DIGOXIN (K760077)Smithkline Diagnostics, Inc.1976-07-16

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Every clearance here is in the API, with alerts when new ones post.