FDA 510(k) Applications for Medical Device Product Code: CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt)

FDA 510(k) Applications for Medical Device Product Code "CKA"
(Nadh Oxidation/Nad Reduction, Alt/Sgpt)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K113382	ALFA WASSERMANN	ACE ALT REAGENT	07/19/2012
K020487	CARESIDE, INC.	CARESIDE ALT	06/04/2002
K971323	CAROLINA LIQUID CHEMISTRIES CORP.	ALT OR SGPT	04/21/1997
K061020	DADE BEHRING, INC.	DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE	05/10/2006
K965134	DERMA MEDIA LAB., INC.	ALT/SGPT	02/18/1997
K974003	DIAGNOSTIC CHEMICALS LTD.	ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30	12/05/1997
K120945	HITACHI CHEMICAL DIAGNOSTICS, INC.	HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST	06/07/2013
K980028	TRACE AMERICA, INC.	ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)	02/02/1998
K973869	TRACE AMERICA, INC.	TRACE REAGENT LINE FOR THE COBAS MIRA	01/07/1998
K961123	TRACE SCIENTIFIC LTD.	ALT INCORPORATING DST	04/25/1996