JQB · Class I · 21 CFR 862.1360

FDA Product Code JQB: Kinetic Method, Gamma-glutamyl Transpeptidase

Leading manufacturers include Em Diagnostic Systems, Inc., Emd Chemicals, Inc. and Sclavo, Inc..

52
Total
52
Cleared
56d
Avg days
1976
Since
52 devices
49–52 of 52
Cleared Feb 26, 1981
GAMMA-GT REAGENT SYSTEM
K810434
American Monitor Corp.
Chemistry · 7d
Cleared Apr 24, 1980
Y-GT TEST, Y-GLUTAMYL TRANSFERASE TEST
K800769
Sclavo, Inc.
Chemistry · 17d
Cleared Feb 14, 1978
GAMA-GPT REAGENT SET
K780071
Medical Analysis Systems, Inc.
Chemistry · 29d
Cleared Dec 02, 1976
DIAGNOSTIC METHOD-8-GLUTAMYLTRANSFERASE
K761090
Technicon Instruments Corp.
Chemistry · 10d