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 American Monitor Corp..

127
Total
127
Cleared
52d
Avg days
1976
Since
127 devices
25–48 of 127
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
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 Aug 19, 1987
MODIFIED ALT (GPT) REAGENT
K872483
Trace Scientific , Ltd.
Chemistry · 56d
Cleared Aug 13, 1987
BIOTROL ALT/TGP MONOREACTIF
K872830
Biotrol, USA, Inc.
Chemistry · 27d
Cleared Mar 06, 1987
ALANINE AMINOTRANSFERASE (ALT)/(GPT)
K870086
Catachem, Inc.
Chemistry · 57d
Cleared Jan 09, 1987
WAKO(TM) AUTOKIT GPT
K864850
Wako Chemicals USA, Inc.
Chemistry · 30d
Cleared Dec 31, 1986
ALANINE AMINO TRANSFERASE ALT/SGPT
K864906
Tech-Co, Inc.
Chemistry · 16d
Cleared Dec 16, 1986
WAKO GPT II - HA
K864335
Wako Chemicals USA, Inc.
Chemistry · 42d
Cleared Nov 28, 1986
EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95
K863962
Em Diagnostic Systems, Inc.
Chemistry · 49d