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
97–120 of 127
Cleared Feb 13, 1980
DURAZYME GPT/ALT
K800115
American Monitor Corp.
Chemistry · 26d
Cleared Jan 21, 1980
ALT REAGENT
K800038
Gilford Diagnostics
Chemistry · 14d
Cleared Sep 24, 1979
SGPT REAGENT SET MODIFICATION
K791641
American Monitor Corp.
Chemistry · 34d
Cleared Jul 17, 1979
SPIN CHEM, DETERMINATION OF ALT (GPT)
K791083
Smithkline Diagnostics, Inc.
Chemistry · 35d
Cleared Jul 17, 1979
PLUS CHEM, DETERMINATION OF ALT (GPT)
K791084
Smithkline Diagnostics, Inc.
Chemistry · 35d
Cleared May 01, 1979
COULTER ACCU-ZYME II GPT REAGENT
K790522
Coulter Electronics, Inc.
Chemistry · 53d
Cleared Feb 15, 1979
SERUM, GLUTAMIC-PYRUVIC
K790016
Fisher Scientific Co., LLC
Chemistry · 43d
Cleared Nov 03, 1978
REAGENT SET, SGPT SERUM GLUTAMIC
K781726
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Jun 13, 1978
SGPT/ALT REAGENT SYSTEM
K780791
American Monitor Corp.
Chemistry · 29d
Cleared May 18, 1978
SINGLE VIAL 10 SGPT-TRIS
K780636
Boehringer Mannheim Corp.
Chemistry · 31d
Cleared May 12, 1978
ALT(GPT) UNI-UV, SGPT
K780462
Sclavo, Inc.
Chemistry · 50d
Cleared Apr 28, 1978
STAC SYSTEM
K780373
Technicon Instruments Corp.
Chemistry · 51d
Cleared Feb 13, 1978
ULTRAZYME PLUS GPT
K780102
Harleco
Chemistry · 24d
Cleared Jan 31, 1978
ALANINE TRANSAMINASE
K780040
Beckman Instruments, Inc.
Chemistry · 22d
Cleared Nov 14, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT
K772030
Harleco
Chemistry · 18d
Cleared Nov 03, 1977
DYNAZYME II GPT 340
K771152
J.T. Baker Chemical Co.
Chemistry · 129d
Cleared Sep 02, 1977
MULTISTAT III ALANINE AMINOTRANSFERASE
K771466
Instrumentation Laboratory CO
Chemistry · 29d
Cleared Aug 02, 1977
SERUM GLUTAMIC PYRUVIC TRANSAMINASE
K770991
Macomb Chemical Co.
Chemistry · 62d
Cleared Jul 14, 1977
ULTRAZYME PLUS GPT
K770882
Harleco
Chemistry · 59d
Cleared Mar 30, 1977
REAGENT GPT, ENZYME
K770314
Icn Pharmaceuticals, Inc.
Chemistry · 42d
Cleared Dec 29, 1976
GEMENI GPT (ALT) ASSAY
K761269
Electro-Nucleonics Laboratories, Inc.
Chemistry · 13d
Cleared Aug 03, 1976
NDC#12739-0010-1 C-ZYME GPT
K760194
Coulter Electronics, Inc.
Chemistry · 28d