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 May 10, 2006
DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
K061020
Dade Behring, Inc.
Chemistry · 27d
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 Jan 13, 1994
ALANINE AMINOTRANSFERASE (ALT) TEST
K935180
Em Diagnostic Systems, Inc.
Chemistry · 79d
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
Cleared Nov 22, 1991
ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43
K914464
Em Diagnostic Systems, Inc.
Chemistry · 46d
Cleared Sep 19, 1991
ABBOTT QUICKSTART ALANINE AMINOTRANSFER
K913846
Em Diagnostic Systems, Inc.
Chemistry · 22d
Cleared Sep 12, 1990
ALANINE AMINOTRANSFERASE TEST
K903198
Em Diagnostic Systems, Inc.
Chemistry · 55d
Cleared Mar 23, 1990
PARAMAX ALANINE AMINOTRANSFERASE REAGENT
K901105
Baxter Healthcare Corp
Chemistry · 15d
Cleared Feb 16, 1990
COBAS READY STAT PROFILE REAGENT STRIP
K896234
Roche Diagnostic Systems, Inc.
Chemistry · 108d
Cleared Jul 20, 1989
ALT REAGENT (PROCEDURE NUMBER 159)
K893560
Sigma Chemical Co.
Chemistry · 72d
Cleared Jul 20, 1989
ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403
K893752
Em Diagnostic Systems, Inc.
Chemistry · 62d
Cleared Apr 10, 1989
ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55)
K890698
Abbott Laboratories
Chemistry · 59d
Cleared Jan 11, 1989
ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652
K884376
Em Diagnostic Systems, Inc.
Chemistry · 85d
Cleared Sep 19, 1988
SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE
K883181
Beckman Instruments, Inc.
Chemistry · 54d
Cleared Jan 21, 1988
EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017
K874586
Em Diagnostic Systems, Inc.
Chemistry · 73d
Cleared Jan 21, 1988
PYRIDOXAL-5-PHOSPHATE TABLETS
K874835
Boehringer Mannheim Corp.
Chemistry · 58d
Cleared Nov 28, 1986
EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95
K863962
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Jul 29, 1986
TWIN GOT-AST IFCC/GPT-ALT IFCC
K861792
Boehringer Mannheim Corp.
Chemistry · 81d
Cleared Apr 21, 1986
VISION SGPT (ALT)
K861002
Abbott Laboratories
Chemistry · 34d
Cleared Oct 05, 1984
ROCHE REAGENT FOR ALT
K843111
Roche Diagnostic Systems, Inc.
Chemistry · 59d
Cleared Sep 20, 1984
SYSTEMATE GPT 67209
K843334
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Aug 12, 1984
SIGMA 59-UV FOR ALANINE AMINOTRANSFER
K842564
Sigma Chemical Co.
Chemistry · 41d

About Product Code CKA - Regulatory Context