JPZ · Class I · 21 CFR 862.1360

FDA Product Code JPZ: Colorimetric Method, Gamma-glutamyl Transpeptidase

Leading manufacturers include Data Medical Associates, Inc., Wako Chemicals USA, Inc. and Technostics Intl..

33
Total
33
Cleared
51d
Avg days
1976
Since

FDA 510(k) Cleared Colorimetric Method, Gamma-glutamyl Transpeptidase Devices (Product Code JPZ)

33 devices
1–24 of 33
Cleared Jul 01, 2002
CARESIDE GGT
K020486
Careside, Inc.
Chemistry · 138d
Cleared Jul 01, 1996
DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE
K961919
Data Medical Associates, Inc.
Chemistry · 45d
Cleared Dec 03, 1992
GAMMA-GT
K923509
Randox Laboratories, Ltd.
Chemistry · 141d
Cleared Sep 09, 1992
KING DIAGNOSTICS GAMMA GT REAGENT
K923091
King Diagnostics, Inc.
Chemistry · 76d
Cleared Feb 26, 1991
GGT REAGENT
K905618
Amresco, Inc.
Chemistry · 74d
Cleared Oct 12, 1990
ROCHE COBAS READY GGT REAGENT
K903304
Roche Diagnostic Systems, Inc.
Chemistry · 80d
Cleared Mar 29, 1990
ELITECH GAMMA GT TEST KIT
K901090
Elite Technology, Inc.
Chemistry · 22d
Cleared Nov 08, 1989
WAKO(TM) AUTOKIT GAMMA-GT
K895984
Wako Chemicals USA, Inc.
Chemistry · 26d
Cleared May 31, 1988
GAMMA GLUTAMYL TRANSFERASE REAGENT SET
K881239
Tech-Neal Scientific, Inc.
Chemistry · 70d
Cleared Feb 11, 1988
MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)
K874903
Simmler, Inc.
Chemistry · 72d
Cleared Jun 11, 1987
GAMMA GLUTAMYLTRANSFERASE REAGENT
K871979
Intersect Systems, Inc.
Chemistry · 20d
Cleared Nov 24, 1986
VISION (TM) GGTP
K864208
Abbott Laboratories
Chemistry · 28d
Cleared Oct 03, 1986
GAMMA GLUTAMYL TRANSFERASE PROCEDURE
K863586
Data Medical Associates, Inc.
Chemistry · 18d
Cleared May 29, 1986
GAMMA GLUTAMYL TRANSFERASE PROCEDURE
K861672
Data Medical Associates, Inc.
Chemistry · 29d
Cleared Apr 07, 1986
G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT
K860723
Trace Scientific , Ltd.
Chemistry · 40d
Cleared Mar 17, 1986
GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET
K860348
Sterling Diagnostics, Inc.
Chemistry · 46d
Cleared Jan 14, 1986
GAMMA GLUTAMYL TRANSPEPTIDASE REAGENT SET
K855156
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET
K855186
Technostics Intl.
Chemistry · 19d
Cleared Mar 19, 1985
GLUTAMYLTRANSFERASE ASSAY KIT
K850788
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 21d
Cleared Aug 10, 1984
TOYO JOZO G-GTP TEST
K842104
Advocacy International, Ltd.
Chemistry · 77d
Cleared Jul 18, 1983
WAKO R-GTP C-TEST
K831639
Wako Chemicals USA, Inc.
Chemistry · 56d
Cleared Nov 22, 1982
RAICHEM & GT REAGENT
K823090
Reagents Applications, Inc.
Chemistry · 34d
Cleared Aug 12, 1982
GILCHEM Y-GT REAGENT
K822149
Gilford Diagnostics
Chemistry · 21d
Cleared Jul 14, 1982
ULTRAZYME PLUS 2GT
K821871
Harleco Diagnostics
Chemistry · 19d

About Product Code JPZ - Regulatory Context