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 |
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