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 Coulter Electronics, Inc..

127
Total
127
Cleared
52d
Avg days
1976
Since
127 devices
25–48 of 127
Cleared Jul 28, 1992
OLYMPUS ALANINE AMINOTRANSFERASE REAGENT
K922884
Olympus Corp.
Chemistry · 42d
Cleared Jun 04, 1992
KING DIAGNOSTICS ALT (GPT) REAGENT
K922109
King Diagnostics, Inc.
Chemistry · 30d
Cleared May 07, 1992
SYNERMED ALT/GPT REAGENT KIT
K921016
Synermed, Inc.
Chemistry · 65d
Cleared Mar 24, 1992
MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD
K920335
Heraeus Kulzer, Inc.
Chemistry · 60d
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 Jan 25, 1991
COULTER DART ALT (GPT) REAGENT
K905767
Coulter Electronics, Inc.
Chemistry · 29d
Cleared Sep 12, 1990
ALANINE AMINOTRANSFERASE TEST
K903198
Em Diagnostic Systems, Inc.
Chemistry · 55d
Cleared Apr 25, 1990
NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522
K901702
American Research Products Co.
Chemistry · 13d
Cleared Apr 03, 1990
TECHNICON AXON SYSTEM REAGENT METHODS
K900905
Technicon Instruments Corp.
Chemistry · 35d
Cleared Mar 23, 1990
PARAMAX ALANINE AMINOTRANSFERASE REAGENT
K901105
Baxter Healthcare Corp
Chemistry · 15d
Cleared Mar 09, 1990
COULTER ALT (GPT) REAGENT
K897163
Coulter Electronics, Inc.
Chemistry · 71d
Cleared Feb 16, 1990
COBAS READY STAT PROFILE REAGENT STRIP
K896234
Roche Diagnostic Systems, Inc.
Chemistry · 108d
Cleared Nov 13, 1989
ALANINE AMINOTRANSFERASE (ALT)
K896001
American Monitor Corp.
Chemistry · 31d
Cleared Jul 27, 1989
TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES
K892930
Technicon Instruments Corp.
Chemistry · 97d
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 Apr 04, 1989
ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT
K891469
Trace Scientific , Ltd.
Chemistry · 20d
Cleared Feb 02, 1989
CLINISTAT SGPT (ALT) SERUM GLUTAMATE PYRUVATE TRAN
K885144
Heraeus Kulzer, Inc.
Chemistry · 49d
Cleared Jan 11, 1989
ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652
K884376
Em Diagnostic Systems, Inc.
Chemistry · 85d
Cleared Jan 03, 1989
ALANINE AMINOTRANSFERASE
K884936
Catachem, Inc.
Chemistry · 39d
Cleared Sep 19, 1988
SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE
K883181
Beckman Instruments, Inc.
Chemistry · 54d
Cleared Apr 05, 1988
MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE
K875079
Miles Laboratories, Inc.
Chemistry · 118d