JPZ · Class I · 21 CFR 862.1360

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

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

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 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 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
Cleared Jun 02, 1982
ULTRAZYME PLUS-GT, #64959 & 65032
K821468
Emd Chemicals, Inc.
Chemistry · 15d
Cleared Jun 28, 1979
COULTER ACCU-ZYME IIY-GT REAGENT KIT
K790812
Coulter Electronics, Inc.
Chemistry · 63d

About Product Code JPZ - Regulatory Context