FDA Product Code
FDA Product Code JPZ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1360
510(k) Clearances — 33 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K020486 | CARESIDE GGT | Careside, Inc. | 2002-07-01 | Traditional | PDF ↗ |
| K961919 | DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE | Data Medical Associates, Inc. | 1996-07-01 | Traditional | PDF ↗ |
| K923509 | GAMMA-GT | Randox Laboratories, Ltd. | 1992-12-03 | Traditional | PDF ↗ |
| K923091 | KING DIAGNOSTICS GAMMA GT REAGENT | King Diagnostics, Inc. | 1992-09-09 | Traditional | PDF ↗ |
| K905618 | GGT REAGENT | Amresco, Inc. | 1991-02-26 | Traditional | PDF ↗ |
| K903304 | ROCHE COBAS READY GGT REAGENT | Roche Diagnostic Systems, Inc. | 1990-10-12 | Traditional | PDF ↗ |
| K901090 | ELITECH GAMMA GT TEST KIT | Elite Technology, Inc. | 1990-03-29 | Traditional | PDF ↗ |
| K895984 | WAKO(TM) AUTOKIT GAMMA-GT | Wako Chemicals USA, Inc. | 1989-11-08 | Traditional | PDF ↗ |
| K881239 | GAMMA GLUTAMYL TRANSFERASE REAGENT SET | Tech-Neal Scientific, Inc. | 1988-05-31 | Traditional | PDF ↗ |
| K874903 | MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) | Simmler, Inc. | 1988-02-11 | Traditional | PDF ↗ |
| K871979 | GAMMA GLUTAMYLTRANSFERASE REAGENT | Intersect Systems, Inc. | 1987-06-11 | Traditional | PDF ↗ |
| K864208 | VISION (TM) GGTP | Abbott Laboratories | 1986-11-24 | Traditional | PDF ↗ |
| K863586 | GAMMA GLUTAMYL TRANSFERASE PROCEDURE | Data Medical Associates, Inc. | 1986-10-03 | Traditional | PDF ↗ |
| K861672 | GAMMA GLUTAMYL TRANSFERASE PROCEDURE | Data Medical Associates, Inc. | 1986-05-29 | Traditional | PDF ↗ |
| K860723 | G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT | Trace Scientific , Ltd. | 1986-04-07 | Traditional | PDF ↗ |
| K860348 | GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET | Sterling Diagnostics, Inc. | 1986-03-17 | Traditional | PDF ↗ |
| K855186 | GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET | Technostics Intl. | 1986-01-14 | Traditional | PDF ↗ |
| K855156 | GAMMA GLUTAMYL TRANSPEPTIDASE REAGENT SET | Technostics Intl. | 1986-01-14 | Traditional | PDF ↗ |
| K850788 | GLUTAMYLTRANSFERASE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1985-03-19 | Traditional | PDF ↗ |
| K842104 | TOYO JOZO G-GTP TEST | Advocacy International, Ltd. | 1984-08-10 | Traditional | PDF ↗ |
| K831639 | WAKO R-GTP C-TEST | Wako Chemicals USA, Inc. | 1983-07-18 | Traditional | PDF ↗ |
| K823090 | RAICHEM & GT REAGENT | Reagents Applications, Inc. | 1982-11-22 | Traditional | PDF ↗ |
| K822149 | GILCHEM Y-GT REAGENT | Gilford Diagnostics | 1982-08-12 | Traditional | PDF ↗ |
| K821871 | ULTRAZYME PLUS 2GT | Harleco Diagnostics | 1982-07-14 | Traditional | PDF ↗ |
| K821468 | ULTRAZYME PLUS-GT, #64959 & 65032 | Emd Chemicals, Inc. | 1982-06-02 | Traditional | PDF ↗ |
| K803089 | GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) | Environmental Chemical Specialties | 1981-01-02 | Traditional | PDF ↗ |
| K790812 | COULTER ACCU-ZYME IIY-GT REAGENT KIT | Coulter Electronics, Inc. | 1979-06-28 | Traditional | PDF ↗ |
| K781533 | SMA/GGT | Technicon Instruments Corp. | 1978-10-03 | Traditional | PDF ↗ |
| K780099 | ULTRAZYME PLUS GT | Harleco | 1978-03-09 | Traditional | PDF ↗ |
| K760711 | REAGENT SYSTEM (NO. SC 135) | Sigma Chemical Co. | 1976-11-30 | Traditional | PDF ↗ |
| K760366 | REAGENT, Y-GT MAX-PACK | Calbiochem | 1976-11-01 | Traditional | PDF ↗ |
| K760346 | ASSAY FOR GAMMA GLUTAMYLTRANSFERASE | Princeton Biomedix | 1976-10-27 | Traditional | PDF ↗ |
| K760025 | ULTRAZYME GT | Harleco | 1976-08-26 | Traditional | PDF ↗ |
Product code JPZ · Class I · Clinical Chemistry. Data: openFDA.