Colorimetric Method, Gamma-Glutamyl Transpeptidase
FDA product code JPZ · Class I (low risk) · 21 CFR 862.1360 · Clinical Chemistry
33510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Data Medical Associates, Inc. 3
- Technostics Intl. 2
- Harleco 2
- Wako Chemicals USA, Inc. 2
- Reagents Applications, Inc. 1
- Careside, Inc. 1
- Intersect Systems, Inc. 1
- Abbott Laboratories 1
- Trace Scientific , Ltd. 1
- Sterling Diagnostics, Inc. 1
- Diagnostic Chemicals, Ltd. (Usa) 1
- Advocacy International, Ltd. 1
- Gilford Diagnostics 1
- Harleco Diagnostics 1
- Emd Chemicals, Inc. 1
- Environmental Chemical Specialties 1
- Coulter Electronics, Inc. 1
- Technicon Instruments Corp. 1
- Sigma Chemical Co. 1
- Calbiochem 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K020486 | Careside GGTJPZ · Traditional | Careside, Inc. | 07/01/2002SE |
| K961919 | Dma Gamma Glutamyltransferase (GGT) ProcedureJPZ · Traditional | Data Medical Associates, Inc. | 07/01/1996SE |
| K923509 | Gamma-GtJPZ · Traditional | Randox Laboratories, Ltd. | 12/03/1992SE |
| K923091 | King Diagnostics Gamma GT ReagentJPZ · Traditional | King Diagnostics, Inc. | 09/09/1992SE |
| K905618 | GGT ReagentJPZ · Traditional | Amresco, Inc. | 02/26/1991SE |
| K903304 | Roche Cobas Ready GGT ReagentJPZ · Traditional | Roche Diagnostic Systems, Inc. | 10/12/1990SE |
| K901090 | Elitech Gamma GT Test KitJPZ · Traditional | Elite Technology, Inc. | 03/29/1990SE |
| K895984 | Wako(Tm) Autokit Gamma-GtJPZ · Traditional | Wako Chemicals USA, Inc. | 11/08/1989SE |
| K881239 | Gamma Glutamyl Transferase Reagent SetJPZ · Traditional | Tech-Neal Scientific, Inc. | 05/31/1988SE |
| K874903 | Multichem(R) Y -Glutamyltransferase (Y -Gt)JPZ · Traditional | Simmler, Inc. | 02/11/1988SE |
| K871979 | Gamma Glutamyltransferase ReagentJPZ · Traditional | Intersect Systems, Inc. | 06/11/1987SE |
| K864208 | Vision (TM) GGTPJPZ · Traditional | Abbott Laboratories | 11/24/1986SE |
| K863586 | Gamma Glutamyl Transferase ProcedureJPZ · Traditional | Data Medical Associates, Inc. | 10/03/1986SE |
| K861672 | Gamma Glutamyl Transferase ProcedureJPZ · Traditional | Data Medical Associates, Inc. | 05/29/1986SE |
| K860723 | G.T. (Gamma-Glutamyl Transferase) ReagentJPZ · Traditional | Trace Scientific , Ltd. | 04/07/1986SE |
| K860348 | Gamma Glutamyl Transpeptidase (GGTP) Reagent SetJPZ · Traditional | Sterling Diagnostics, Inc. | 03/17/1986SE |
| K855186 | Gamma Glutamyl Transpeptidase (Kinectic)ReagentsetJPZ · Traditional | Technostics Intl. | 01/14/1986SE |
| K855156 | Gamma Glutamyl Transpeptidase Reagent SetJPZ · Traditional | Technostics Intl. | 01/14/1986SE |
| K850788 | Glutamyltransferase Assay KitJPZ · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 03/19/1985SE |
| K842104 | Toyo Jozo G-Gtp TestJPZ · Traditional | Advocacy International, Ltd. | 08/10/1984SE |
| K831639 | Wako R-Gtp C-TestJPZ · Traditional | Wako Chemicals USA, Inc. | 07/18/1983SE |
| K823090 | Raichem & GT ReagentJPZ · Traditional | Reagents Applications, Inc. | 11/22/1982SE |
| K822149 | Gilchem Y-Gt ReagentJPZ · Traditional | Gilford Diagnostics | 08/12/1982SE |
| K821871 | Ultrazyme Plus 2GTJPZ · Traditional | Harleco Diagnostics | 07/14/1982SE |
| K821468 | Ultrazyme Plus-Gt, #64959 & 65032JPZ · Traditional | Emd Chemicals, Inc. | 06/02/1982SE |
| K803089 | Gamma-Glutamyl Transpeptidase (GGT)JPZ · Traditional | Environmental Chemical Specialties | 01/02/1981SE |
| K790812 | Coulter Accu-Zyme Iiy-Gt Reagent KitJPZ · Traditional | Coulter Electronics, Inc. | 06/28/1979SE |
| K781533 | Sma/GgtJPZ · Traditional | Technicon Instruments Corp. | 10/03/1978SE |
| K780099 | Ultrazyme Plus GTJPZ · Traditional | Harleco | 03/09/1978SE |
| K760711 | Reagent System (No. SC 135)JPZ · Traditional | Sigma Chemical Co. | 11/30/1976SE |
| K760366 | Reagent, Y-Gt Max-PackJPZ · Traditional | Calbiochem | 11/01/1976SE |
| K760346 | Assay for Gamma GlutamyltransferaseJPZ · Traditional | Princeton Biomedix | 10/27/1976SE |
| K760025 | Ultrazyme GTJPZ · Traditional | Harleco | 08/26/1976SE |