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 Harleco.

127
Total
127
Cleared
52d
Avg days
1976
Since
127 devices
49–72 of 127
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 (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
Cleared Dec 25, 1985
IN VITRO TEST DETERMINATION OF SGPT(ALT)
K854186
Clinical Data, Inc.
Chemistry · 71d
Cleared Nov 25, 1985
ALT(OPTIMIZED) REAGENT
K854502
Sigma Diagnostics, Inc.
Chemistry · 13d
Cleared Aug 29, 1985
HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE
K852867
Hi Chem, Inc.
Chemistry · 52d
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 20, 1982
ALT ENZYME ASSAY KIT
K821946
Travenol Laboratories, S.A.
Chemistry · 20d
Cleared Jul 02, 1982
PYRIDOXAL-5-PHOSPHATE STRIPES
K821805
Boehringer Mannheim Corp.
Chemistry · 15d
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