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
127 devices
73–96 of 127
Cleared May 30, 1985
ALT (ALANINE AMINO-THRANSFERASE)REAGENT
K851995
Alpkem Corp.
Chemistry · 23d
Cleared May 24, 1985
AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE
K851923
Amresco, Inc.
Chemistry · 22d
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
Cleared Jul 18, 1984
ALANINE AMINOTRANSFERASE ASSAY KIT
K842241
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 43d
Cleared May 01, 1984
SGPT REAGENT SET
K841060
Medical Specialties, Inc.
Chemistry · 50d
Cleared Mar 09, 1984
PARAMAX ALANINE AMINOTRANSFERASE
K840705
American Dade
Hematology · 21d
Cleared Sep 12, 1983
ALT -LTS
K832639
Electro-Nucleonics Laboratories, Inc.
Chemistry · 39d
Cleared May 04, 1983
FLOW-PAC SGPT REAGENT
K830959
Amresco, Inc.
Chemistry · 40d
Cleared Jul 22, 1982
SGPT-UV REAGENT SET
K821206
Omega Medical Electronics
Chemistry · 86d
Cleared Jul 20, 1982
ALT ENZYME ASSAY KIT
K821946
Travenol Laboratories, S.A.
Chemistry · 20d
Cleared Jul 14, 1982
ULTRAZYME PLUS GPT
K821882
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 02, 1982
PYRIDOXAL-5-PHOSPHATE STRIPES
K821805
Boehringer Mannheim Corp.
Chemistry · 15d
Cleared Jun 14, 1982
DOWFLOW ALT-UV DETERMINATION
K821536
The Dow Chemical Co.
Chemistry · 21d
Cleared May 03, 1982
LIQUID-STAT TM AST-UV LIQUID ENZUNE
K821048
Beckman Instruments, Inc.
Chemistry · 18d
Cleared Mar 15, 1982
RAICHEM GPT (ALT) REAGENT
K820525
Reagents Applications, Inc.
Chemistry · 17d
Cleared Mar 08, 1982
TECHNICON RA-1000 SYSTEM ADD. ANALYT
K820394
Technicon Instruments Corp.
Chemistry · 25d
Cleared Dec 31, 1981
ALT (SGPT)
K813495
Pointe Scientific, Inc.,
Chemistry · 17d
Cleared Nov 06, 1981
ALT-QUANTICHROM
K812926
Abbott Laboratories
Chemistry · 18d
Cleared Sep 24, 1981
ULTRA ZYME PLUS GPT, #64956, 65035 & 36
K812591
Harleco
Chemistry · 13d
Cleared Feb 23, 1981
ALT (UV) TEST
K810355
Boehringer Mannheim Corp.
Chemistry · 13d
Cleared Sep 16, 1980
DATA-ZYME LAT(GPT) PROCEDURE
K801857
Data Medical Associates, Inc.
Chemistry · 43d
Cleared May 30, 1980
REAGENT FOR DETERM. GLUTAMIC-PYRUVIC-
K800689
Diagnostic Solutions, Inc.
Chemistry · 65d