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CKA

127 FDA 510(k) clearances · Product code

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RecordFirmDate
ALT (UV) TEST (K810355)Boehringer Mannheim Corp.1981-02-23
DATA-ZYME LAT(GPT) PROCEDURE (K801857)Data Medical Associates, Inc.1980-09-16
COBAS REAGENT FOR ALT (GPT) (K801119)Roche Analytical Instruments, Inc.1980-06-09
REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- (K800689)Diagnostic Solutions, Inc.1980-05-30
DURAZYME GPT/ALT (K800115)American Monitor Corp.1980-02-13
ALT REAGENT (K800038)Gilford Diagnostics1980-01-21
SGPT REAGENT SET MODIFICATION (K791641)American Monitor Corp.1979-09-24
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
COULTER ACCU-ZYME II GPT REAGENT (K790522)Coulter Electronics, Inc.1979-05-01
SERUM, GLUTAMIC-PYRUVIC (K790016)Fisher Scientific Co., LLC1979-02-15
REAGENT SET, SGPT SERUM GLUTAMIC (K781726)Medical Analysis Systems, Inc.1978-11-03
SGPT/ALT REAGENT SYSTEM (K780791)American Monitor Corp.1978-06-13
SINGLE VIAL 10 SGPT-TRIS (K780636)Boehringer Mannheim Corp.1978-05-18
ALT(GPT) UNI-UV, SGPT (K780462)Sclavo, Inc.1978-05-12
STAC SYSTEM (K780373)Technicon Instruments Corp.1978-04-28
ULTRAZYME PLUS GPT (K780102)Harleco1978-02-13
ALANINE TRANSAMINASE (K780040)Beckman Instruments, Inc.1978-01-31
GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT (K772030)Harleco1977-11-14
DYNAZYME II GPT 340 (K771152)J.T. Baker Chemical Co.1977-11-03
MULTISTAT III ALANINE AMINOTRANSFERASE (K771466)Instrumentation Laboratory CO1977-09-02
SMAC SYS., SUPPLEMENTAL PRODUCTS FOR (K771033)Mid Tech, Inc.1977-08-04
SERUM GLUTAMIC PYRUVIC TRANSAMINASE (K770991)Macomb Chemical Co.1977-08-02
ULTRAZYME PLUS GPT (K770882)Harleco1977-07-14
REAGENT GPT, ENZYME (K770314)Icn Pharmaceuticals, Inc.1977-03-30
GEMENI GPT (ALT) ASSAY (K761269)Electro-Nucleonics Laboratories, Inc.1976-12-29
NDC#12739-0010-1 C-ZYME GPT (K760194)Coulter Electronics, Inc.1976-08-03
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