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
49–72 of 127
Cleared Sep 09, 1988
ALTLTS ALANINE AMINO TRANSFERASE ALT
K883205
Electro-Nucleonics, Inc.
Chemistry · 43d
Cleared Apr 05, 1988
MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE
K875079
Miles Laboratories, Inc.
Chemistry · 118d
Cleared Mar 01, 1988
ALT (SGPT) REAGENT SET
K880275
Tech-Neal Scientific, Inc.
Chemistry · 40d
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 May 26, 1987
ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT)
K871782
Biochemical Trade, Inc.
Chemistry · 20d
Cleared Mar 19, 1987
ALANINE TRANSAMINASE (ALT) TEST KIT
K870879
Genetic Systems Corp.
Chemistry · 15d
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 Dec 10, 1986
ALT S.C.E. (GPT)
K863053
J. D. Assoc.
Chemistry · 120d
Cleared Nov 28, 1986
EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95
K863962
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Sep 16, 1986
ALT/GPT PROCEDURE
K863253
Data Medical Associates, Inc.
Chemistry · 22d
Cleared Aug 19, 1986
MODEL 303-47/303-48 ALANINE AMINOTRANSFERASE KIT
K862833
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 25d
Cleared Jul 29, 1986
TWIN GOT-AST IFCC/GPT-ALT IFCC
K861792
Boehringer Mannheim Corp.
Chemistry · 81d
Cleared Jun 25, 1986
ALT-30, 60 AND 100
K861366
Dimension Diagnostics
Chemistry · 75d
Cleared Jun 25, 1986
ALT (SGPT) REAGENT SET (UV RATE)
K862209
Sterling Diagnostics, Inc.
Chemistry · 15d
Cleared May 29, 1986
ALT/GPT PROCEDURE
K861658
Data Medical Associates, Inc.
Chemistry · 29d
Cleared Apr 28, 1986
ALT REAGENT CARTRIDGE (PRODUCT NO. 88210)
K861231
Hi Chem, Inc.
Chemistry · 27d
Cleared Apr 21, 1986
VISION SGPT (ALT)
K861002
Abbott Laboratories
Chemistry · 34d
Cleared Apr 07, 1986
ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT
K860727
Trace Scientific , Ltd.
Chemistry · 40d