Atlas FDA

JPZ

33 FDA 510(k) clearances · Product code

45 daysmedian time to decision
86 days90th percentile
33clearances measured

FDA profile

Official device name
Colorimetric Method, Gamma-Glutamyl Transpeptidase
Device class
Class I (low risk)
Regulation
21 CFR 862.1360
Medical specialty
Clinical Chemistry
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RecordFirmDate
CARESIDE GGT (K020486)Careside, Inc.2002-07-01
DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE (K961919)Data Medical Associates, Inc.1996-07-01
GAMMA-GT (K923509)Randox Laboratories, Ltd.1992-12-03
KING DIAGNOSTICS GAMMA GT REAGENT (K923091)King Diagnostics, Inc.1992-09-09
GGT REAGENT (K905618)Amresco, Inc.1991-02-26
ROCHE COBAS READY GGT REAGENT (K903304)Roche Diagnostic Systems, Inc.1990-10-12
ELITECH GAMMA GT TEST KIT (K901090)Elite Technology, Inc.1990-03-29
WAKO(TM) AUTOKIT GAMMA-GT (K895984)Wako Chemicals USA, Inc.1989-11-08
GAMMA GLUTAMYL TRANSFERASE REAGENT SET (K881239)Tech-Neal Scientific, Inc.1988-05-31
MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) (K874903)Simmler, Inc.1988-02-11
GAMMA GLUTAMYLTRANSFERASE REAGENT (K871979)Intersect Systems, Inc.1987-06-11
VISION (TM) GGTP (K864208)Abbott Laboratories1986-11-24
GAMMA GLUTAMYL TRANSFERASE PROCEDURE (K863586)Data Medical Associates, Inc.1986-10-03
GAMMA GLUTAMYL TRANSFERASE PROCEDURE (K861672)Data Medical Associates, Inc.1986-05-29
G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT (K860723)Trace Scientific , Ltd.1986-04-07
GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET (K860348)Sterling Diagnostics, Inc.1986-03-17
GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET (K855186)Technostics Intl.1986-01-14
GAMMA GLUTAMYL TRANSPEPTIDASE REAGENT SET (K855156)Technostics Intl.1986-01-14
GLUTAMYLTRANSFERASE ASSAY KIT (K850788)Diagnostic Chemicals, Ltd. (Usa)1985-03-19
TOYO JOZO G-GTP TEST (K842104)Advocacy International, Ltd.1984-08-10
WAKO R-GTP C-TEST (K831639)Wako Chemicals USA, Inc.1983-07-18
RAICHEM & GT REAGENT (K823090)Reagents Applications, Inc.1982-11-22
GILCHEM Y-GT REAGENT (K822149)Gilford Diagnostics1982-08-12
ULTRAZYME PLUS 2GT (K821871)Harleco Diagnostics1982-07-14
ULTRAZYME PLUS-GT, #64959 & 65032 (K821468)Emd Chemicals, Inc.1982-06-02
GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) (K803089)Environmental Chemical Specialties1981-01-02
COULTER ACCU-ZYME IIY-GT REAGENT KIT (K790812)Coulter Electronics, Inc.1979-06-28
SMA/GGT (K781533)Technicon Instruments Corp.1978-10-03
ULTRAZYME PLUS GT (K780099)Harleco1978-03-09
REAGENT SYSTEM (NO. SC 135) (K760711)Sigma Chemical Co.1976-11-30
REAGENT, Y-GT MAX-PACK (K760366)Calbiochem1976-11-01
ASSAY FOR GAMMA GLUTAMYLTRANSFERASE (K760346)Princeton Biomedix1976-10-27
ULTRAZYME GT (K760025)Harleco1976-08-26

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