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
121–127 of 127
Cleared Sep 02, 1977
MULTISTAT III ALANINE AMINOTRANSFERASE
K771466
Instrumentation Laboratory CO
Chemistry · 29d
Cleared Aug 04, 1977
SMAC SYS., SUPPLEMENTAL PRODUCTS FOR
K771033
Mid Tech, Inc.
Chemistry · 56d
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