JQB · Class I · 21 CFR 862.1360

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

Leading manufacturers include Em Diagnostic Systems, Inc. and Roche Diagnostic Systems, Inc..

52
Total
52
Cleared
56d
Avg days
1976
Since

FDA 510(k) Cleared Kinetic Method, Gamma-glutamyl Transpeptidase Devices (Product Code JQB)

52 devices
1–24 of 52
Cleared Jan 13, 1997
ROCHE COBAS IBTEGRA REAGENT CASSETTES
K964457
Roche Diagnostic Systems, Inc.
Chemistry · 68d
Cleared Dec 16, 1993
GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
K935177
Em Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Nov 18, 1992
ROCHE REAGENT FOR GGT
K924246
Roche Diagnostic Systems, Inc.
Chemistry · 86d
Cleared Sep 28, 1992
GAMMA GULTAMYL TRANSFERASE TEST
K922947
Em Diagnostic Systems, Inc.
Chemistry · 102d
Cleared Jul 26, 1991
ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST
K913024
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Jan 04, 1991
SYSTEMATE GGT (EPOS APPLICATION) #65414
K905662
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Jul 20, 1989
GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1
K893765
Em Diagnostic Systems, Inc.
Chemistry · 62d
Cleared Jan 13, 1989
GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664
K884988
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Jul 27, 1987
EASY-TEST GAMMA-GLUTAMYL TRANSFERASE (GGT) 16616
K872320
Em Diagnostic Systems, Inc.
Chemistry · 40d
Cleared Jul 27, 1987
EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95
K872322
Em Diagnostic Systems, Inc.
Chemistry · 40d
Cleared Apr 09, 1986
EASY-TEST (GGT) REAGENT, ITEM NO. 67526/93
K860640
Em Diagnostic Systems, Inc.
Chemistry · 48d
Cleared Sep 13, 1984
SYSTEMATE 2GT - 67207
K843268
Em Diagnostic Systems, Inc.
Chemistry · 24d

About Product Code JQB - Regulatory Context