Product code JPZ
- Device name
- Colorimetric Method, Gamma-Glutamyl Transpeptidase
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1360
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K020486 | CARESIDE GGT | Careside, Inc. | 2002-07-01 |
| K961919 | DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE | Data Medical Associates, Inc. | 1996-07-01 |
| K923509 | GAMMA-GT | Randox Laboratories, Ltd. | 1992-12-03 |
| K923091 | KING DIAGNOSTICS GAMMA GT REAGENT | King Diagnostics, Inc. | 1992-09-09 |
| K905618 | GGT REAGENT | Amresco, Inc. | 1991-02-26 |
| K903304 | ROCHE COBAS READY GGT REAGENT | Roche Diagnostic Systems, Inc. | 1990-10-12 |
| K901090 | ELITECH GAMMA GT TEST KIT | Elite Technology, Inc. | 1990-03-29 |
| K895984 | WAKO(TM) AUTOKIT GAMMA-GT | Wako Chemicals USA, Inc. | 1989-11-08 |
| K881239 | GAMMA GLUTAMYL TRANSFERASE REAGENT SET | Tech-Neal Scientific, Inc. | 1988-05-31 |
| K874903 | MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) | Simmler, Inc. | 1988-02-11 |
| K871979 | GAMMA GLUTAMYLTRANSFERASE REAGENT | Intersect Systems, Inc. | 1987-06-11 |
| K864208 | VISION (TM) GGTP | Abbott Laboratories | 1986-11-24 |
| K863586 | GAMMA GLUTAMYL TRANSFERASE PROCEDURE | Data Medical Associates, Inc. | 1986-10-03 |
| K861672 | GAMMA GLUTAMYL TRANSFERASE PROCEDURE | Data Medical Associates, Inc. | 1986-05-29 |
| K860723 | G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT | Trace Scientific , Ltd. | 1986-04-07 |
| K860348 | GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET | Sterling Diagnostics, Inc. | 1986-03-17 |
| K855156 | GAMMA GLUTAMYL TRANSPEPTIDASE REAGENT SET | Technostics Intl. | 1986-01-14 |
| K855186 | GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET | Technostics Intl. | 1986-01-14 |
| K850788 | GLUTAMYLTRANSFERASE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1985-03-19 |
| K842104 | TOYO JOZO G-GTP TEST | Advocacy International, Ltd. | 1984-08-10 |
| K831639 | WAKO R-GTP C-TEST | Wako Chemicals USA, Inc. | 1983-07-18 |
| K823090 | RAICHEM & GT REAGENT | Reagents Applications, Inc. | 1982-11-22 |
| K822149 | GILCHEM Y-GT REAGENT | Gilford Diagnostics | 1982-08-12 |
| K821871 | ULTRAZYME PLUS 2GT | Harleco Diagnostics | 1982-07-14 |
| K821468 | ULTRAZYME PLUS-GT, #64959 & 65032 | Emd Chemicals, Inc. | 1982-06-02 |
| K803089 | GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) | Environmental Chemical Specialties | 1981-01-02 |
| K790812 | COULTER ACCU-ZYME IIY-GT REAGENT KIT | Coulter Electronics, Inc. | 1979-06-28 |
| K781533 | SMA/GGT | Technicon Instruments Corp. | 1978-10-03 |
| K780099 | ULTRAZYME PLUS GT | Harleco | 1978-03-09 |
| K760711 | REAGENT SYSTEM (NO. SC 135) | Sigma Chemical Co. | 1976-11-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06971674861676 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861683 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861713 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861720 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861737 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861744 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861768 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861799 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861805 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861812 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861829 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861836 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861843 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861706 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674861782 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674861775 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674861751 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674861690 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 05055273203462 | GAMMA-GLUTAMYLTRANSERASE (GGT) | RANDOX LABORATORIES LIMITED | 2022-09-22 |
| 05055273208801 | GAMMA-GLUTAMYLTRANSERASE (GGT) | RANDOX LABORATORIES LIMITED | 2022-09-22 |
| 05055273215502 | GAMMA-GLUTAMYLTRANSERASE (GGT) | RANDOX LABORATORIES LIMITED | 2022-09-22 |
| 00817302024159 | CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT BL209 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-08-19 |
| 00817302024395 | CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT DT209 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-08-19 |
| 00817302024531 | CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT ST209 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-08-19 |
| 00380740155308 | Alinity | ABBOTT IRELAND | 2022-06-14 |
| 00380740155315 | Alinity | ABBOTT IRELAND | 2022-06-14 |
| 00380740155896 | ARCHITECT | ABBOTT IRELAND | 2022-06-14 |
| 00380740155902 | ARCHITECT | ABBOTT IRELAND | 2022-06-14 |
| 00380740161712 | ARCHITECT | Abbott GmbH | 2020-02-29 |
| 00015482771140 | SPOTCHEM™ II GGT | ARKRAY USA, INC. | 2016-09-23 |