CKA · Class I · 21 CFR 862.1030

FDA Product Code CKA: Nadh Oxidation/nad Reduction, Alt/sgpt

Leading manufacturers include Em Diagnostic Systems, Inc., Boehringer Mannheim Corp. and Beckman Instruments, Inc..

127
Total
127
Cleared
52d
Avg days
1976
Since

FDA 510(k) Cleared Nadh Oxidation/nad Reduction, Alt/sgpt Devices (Product Code CKA)

127 devices
1–24 of 127
Cleared Jun 07, 2013
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST
K120945
Hitachi Chemical Diagnostics, Inc.
Chemistry · 435d
Cleared Jul 19, 2012
ACE ALT REAGENT
K113382
Alfa Wassermann
Chemistry · 246d
Cleared May 10, 2006
DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
K061020
Dade Behring, Inc.
Chemistry · 27d
Cleared Jun 04, 2002
CARESIDE ALT
K020487
Careside, Inc.
Chemistry · 111d
Cleared Feb 02, 1998
ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
K980028
Trace America, Inc.
Chemistry · 28d
Cleared Jan 07, 1998
TRACE REAGENT LINE FOR THE COBAS MIRA
K973869
Trace America, Inc.
Chemistry · 105d
Cleared Dec 05, 1997
ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30
K974003
Diagnostic Chemicals , Ltd.
Chemistry · 45d
Cleared Apr 21, 1997
ALT OR SGPT
K971323
Carolina Liquid Chemistries Corp.
Chemistry · 11d
Cleared Feb 18, 1997
ALT/SGPT
K965134
Derma Media Lab., Inc.
Chemistry · 57d
Cleared Apr 25, 1996
ALT INCORPORATING DST
K961123
Trace Scientific , Ltd.
Chemistry · 35d
Cleared Sep 21, 1995
CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE
K952427
Beckman Instruments, Inc.
Chemistry · 120d
Cleared Aug 07, 1995
ALANINE AMINOTRANSFERASE REAGENT SYSTEM
K952744
Medical Diagnostic Technologies, Inc.
Chemistry · 52d
Cleared Jun 19, 1995
PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT
K951332
Dade Intl., Inc.
Chemistry · 102d
Cleared May 15, 1995
HICHEM ALT REAGENT KIT
K951818
Hi Chem, Inc.
Chemistry · 25d
Cleared Nov 22, 1994
ALT QVET
K944080
Prisma Systems
Chemistry · 92d
Cleared Jul 20, 1994
STANBIO ALT/GPT (LUQUI-UV) TEST SET
K941314
Stanbio Laboratory
Chemistry · 124d
Cleared May 03, 1994
LIQUID ALT(SGPT) REAGENT SET
K941287
Pointe Scientific, Inc.,
Chemistry · 47d
Cleared Jan 13, 1994
ALANINE AMINOTRANSFERASE (ALT) TEST
K935180
Em Diagnostic Systems, Inc.
Chemistry · 79d
Cleared Apr 08, 1993
HEMOCARD HEMOGLOBIN E
K930070
Isolab, Inc.
Hematology · 92d
Cleared Feb 05, 1993
OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT
K925339
Olympus Corp.
Chemistry · 108d
Cleared Nov 16, 1992
ALT (GPT) - ALANINE AMINOTRANSFERASE
K923510
Randox Laboratories, Ltd.
Chemistry · 124d
Cleared Oct 22, 1992
ROCHE REAGENT FOR ALT
K924245
Roche Diagnostic Systems, Inc.
Chemistry · 59d
Cleared Sep 28, 1992
EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000
K923257
Em Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Sep 17, 1992
IL TEST ALT, PN 35311
K923623
Instrumentation Laboratory CO
Chemistry · 58d

About Product Code CKA - Regulatory Context