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 Diagnostic Chemicals , Ltd..

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 Nov 04, 1997
Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30
K974000
Diagnostic Chemicals , Ltd.
Chemistry · 14d
Cleared Oct 10, 1997
LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET
K973157
Pointe Scientific, Inc.,
Chemistry · 49d
Cleared Jan 13, 1997
ROCHE COBAS IBTEGRA REAGENT CASSETTES
K964457
Roche Diagnostic Systems, Inc.
Chemistry · 68d
Cleared Jun 09, 1995
Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05
K945800
Diagnostic Chemicals , Ltd.
Chemistry · 193d
Cleared May 02, 1995
HICHEM Y-GT REAGENT KIT
K946192
Hichem Diagnostics
Chemistry · 133d
Cleared Jul 20, 1994
GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419
K935984
Sigma Diagnostics, Inc.
Chemistry · 218d
Cleared Jul 14, 1994
STANBIO Y-GT (LIQUICOLOR) TEST SET
K941315
Stanbio Laboratory
Chemistry · 118d
Cleared Dec 16, 1993
GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
K935177
Em Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Sep 08, 1993
SYNERMED GGT REAGENT KIT
K931958
Synermed, Inc.
Chemistry · 141d
Cleared Jan 26, 1993
OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT
K925337
Olympus Corp.
Chemistry · 98d
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 Jun 25, 1992
OLYMPUS GGT REAGENT
K922230
Olympus Corp.
Chemistry · 44d
Cleared Nov 19, 1991
TRACE GAMMA GT-SS REAGENT
K914731
Trace Scientific , Ltd.
Chemistry · 29d
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 Dec 20, 1990
RAICHEM GGT REAGENT
K905085
Reagents Applications, Inc.
Chemistry · 36d
Cleared Nov 28, 1990
GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138
K905096
Amresco, Inc.
Chemistry · 15d
Cleared Apr 16, 1990
COULTER GAMMA-GT (GGT) REAGENT
K901264
Coulter Corp.
Chemistry · 31d
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

About Product Code JQB - Regulatory Context