Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JPZ — Predicate Candidate Screening
33 FDA 510(k) clearances under this product code; the 50 most recent screened below.
45 daysmedian FDA review time
86 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K020486 | CARESIDE GGT | Careside, Inc. | 2002-07-01 | 138 | 0 |
| K961919 | DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE | Data Medical Associates, Inc. | 1996-07-01 | 45 | 0 |
| K923509 | GAMMA-GT | Randox Laboratories, Ltd. | 1992-12-03 | 141 | 0 |
| K923091 | KING DIAGNOSTICS GAMMA GT REAGENT | King Diagnostics, Inc. | 1992-09-09 | 76 | 0 |
| K905618 | GGT REAGENT | Amresco, Inc. | 1991-02-26 | 74 | 0 |
| K903304 | ROCHE COBAS READY GGT REAGENT | Roche Diagnostic Systems, Inc. | 1990-10-12 | 80 | 0 |
| K901090 | ELITECH GAMMA GT TEST KIT | Elite Technology, Inc. | 1990-03-29 | 22 | 0 |
| K895984 | WAKO(TM) AUTOKIT GAMMA-GT | Wako Chemicals USA, Inc. | 1989-11-08 | 26 | 0 |
| K881239 | GAMMA GLUTAMYL TRANSFERASE REAGENT SET | Tech-Neal Scientific, Inc. | 1988-05-31 | 70 | 0 |
| K874903 | MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) | Simmler, Inc. | 1988-02-11 | 72 | 0 |
| K871979 | GAMMA GLUTAMYLTRANSFERASE REAGENT | Intersect Systems, Inc. | 1987-06-11 | 20 | 0 |
| K864208 | VISION (TM) GGTP | Abbott Laboratories | 1986-11-24 | 28 | 0 |
| K863586 | GAMMA GLUTAMYL TRANSFERASE PROCEDURE | Data Medical Associates, Inc. | 1986-10-03 | 18 | 0 |
| K861672 | GAMMA GLUTAMYL TRANSFERASE PROCEDURE | Data Medical Associates, Inc. | 1986-05-29 | 29 | 0 |
| K860723 | G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT | Trace Scientific , Ltd. | 1986-04-07 | 40 | 0 |
| K860348 | GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET | Sterling Diagnostics, Inc. | 1986-03-17 | 46 | 0 |
| K855186 | GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET | Technostics Intl. | 1986-01-14 | 19 | 0 |
| K855156 | GAMMA GLUTAMYL TRANSPEPTIDASE REAGENT SET | Technostics Intl. | 1986-01-14 | 19 | 0 |
| K850788 | GLUTAMYLTRANSFERASE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1985-03-19 | 21 | 0 |
| K842104 | TOYO JOZO G-GTP TEST | Advocacy International, Ltd. | 1984-08-10 | 77 | 0 |
| K831639 | WAKO R-GTP C-TEST | Wako Chemicals USA, Inc. | 1983-07-18 | 56 | 0 |
| K823090 | RAICHEM & GT REAGENT | Reagents Applications, Inc. | 1982-11-22 | 34 | 0 |
| K822149 | GILCHEM Y-GT REAGENT | Gilford Diagnostics | 1982-08-12 | 21 | 0 |
| K821871 | ULTRAZYME PLUS 2GT | Harleco Diagnostics | 1982-07-14 | 19 | 0 |
| K821468 | ULTRAZYME PLUS-GT, #64959 & 65032 | Emd Chemicals, Inc. | 1982-06-02 | 15 | 0 |
| K803089 | GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) | Environmental Chemical Specialties | 1981-01-02 | 25 | 0 |
| K790812 | COULTER ACCU-ZYME IIY-GT REAGENT KIT | Coulter Electronics, Inc. | 1979-06-28 | 63 | 0 |
| K781533 | SMA/GGT | Technicon Instruments Corp. | 1978-10-03 | 27 | 0 |
| K780099 | ULTRAZYME PLUS GT | Harleco | 1978-03-09 | 48 | 0 |
| K760711 | REAGENT SYSTEM (NO. SC 135) | Sigma Chemical Co. | 1976-11-30 | 66 | 0 |
| K760366 | REAGENT, Y-GT MAX-PACK | Calbiochem | 1976-11-01 | 89 | 0 |
| K760346 | ASSAY FOR GAMMA GLUTAMYLTRANSFERASE | Princeton Biomedix | 1976-10-27 | 86 | 0 |
| K760025 | ULTRAZYME GT | Harleco | 1976-08-26 | 73 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda