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 Sigma Diagnostics, Inc..

52
Total
52
Cleared
56d
Avg days
1976
Since
52 devices
25–48 of 52
Cleared Jul 20, 1989
GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1
K893765
Em Diagnostic Systems, Inc.
Chemistry · 62d
Cleared Mar 24, 1989
GAMMA-GLUTAMYLTRANSFERASE
K890312
American Monitor Corp.
Chemistry · 60d
Cleared Jan 13, 1989
GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664
K884988
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared May 27, 1988
GAMMA-GLUTAMYL TRANSFERASE
K881626
Tech-Co, Inc.
Chemistry · 45d
Cleared Apr 28, 1988
BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
K881311
Biotrol, USA, Inc.
Chemistry · 31d
Cleared Sep 08, 1987
GAMMA GLUTAMYLTRANSFERASE
K873378
Catachem, Inc.
Chemistry · 15d
Cleared Sep 04, 1987
UNIFAST GAMMA-GT
K873135
Sclavo, Inc.
Chemistry · 25d
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 Jun 10, 1985
G-GT REAGENT
K851999
Alpkem Corp.
Chemistry · 34d
Cleared Feb 12, 1985
Y-GLUTAMYLTRANSFERASE(Y-GT) REAGENT
K850319
Sigma Diagnostics, Inc.
Chemistry · 15d
Cleared Dec 12, 1984
GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED
K844720
Data Medical Associates, Inc.
Chemistry · 8d
Cleared Sep 13, 1984
SYSTEMATE 2GT - 67207
K843268
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Feb 04, 1984
DART GAMMA-GT REAGENT SYSTEM
K834054
Coulter Electronics, Inc.
Chemistry · 73d
Cleared Dec 29, 1983
FLOW-PAC GGT REAGENT SET
K833029
American Research Products Co.
Chemistry · 113d
Cleared Oct 14, 1983
PARAMAX & GLUTAMYTRANSFERASE REAGENT
K833001
American Dade
Chemistry · 63d
Cleared Feb 28, 1983
ULTRA ZYME PLUS GAMMA GT #65055 & 56
K830308
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Feb 18, 1983
ULTRAZYME PLUS GAMMA GT-MCA #65055-65056
K830240
Emd Chemicals, Inc.
Chemistry · 24d
Cleared Feb 18, 1983
CAST SHOE, CAST BOOT
K830246
Warm & Form, Orthopedic Materials
Chemistry · 24d
Cleared Jan 28, 1983
ULTRAZYME PLUS GAMMA-GT, #64959/65032
K823883
Emd Chemicals, Inc.
Chemistry · 32d
Cleared Feb 12, 1982
ULTRAZYME PLUS GAMMA GT(65055-65056)
K820233
Harleco
Chemistry · 15d
Cleared Nov 10, 1981
ULTRAZYME-GT, ITEM #64959 & 65032
K813041
Harleco
Chemistry · 13d
Cleared Aug 31, 1981
GAMMA GLUTAMY TRANSPEPTIDASE
K812296
Pointe Scientific, Inc.,
Chemistry · 17d