Product code JQB
- Device name
- Kinetic 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 |
|---|---|---|---|
| K974000 | Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30 | Diagnostic Chemicals , Ltd. | 1997-11-04 |
| K973157 | LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET | Pointe Scientific, Inc., | 1997-10-10 |
| K971466 | SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT) | Carolina Liquid Chemistries Corp. | 1997-05-06 |
| K964457 | ROCHE COBAS IBTEGRA REAGENT CASSETTES | Roche Diagnostic Systems, Inc. | 1997-01-13 |
| K964916 | GAMMA-GLUTAMYL TRANSPEPTIDASE | Derma Media Lab., Inc. | 1997-01-10 |
| K955770 | GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM | Abaxis, Inc. | 1996-09-09 |
| K945800 | Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05 | Diagnostic Chemicals , Ltd. | 1995-06-09 |
| K946192 | HICHEM Y-GT REAGENT KIT | Hichem Diagnostics | 1995-05-02 |
| K942962 | GGT QVET | Prisma Systems | 1994-12-07 |
| K935984 | GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419 | Sigma Diagnostics, Inc. | 1994-07-20 |
| K941315 | STANBIO Y-GT (LIQUICOLOR) TEST SET | Stanbio Laboratory | 1994-07-14 |
| K935177 | GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST | Em Diagnostic Systems, Inc. | 1993-12-16 |
| K931958 | SYNERMED GGT REAGENT KIT | Synermed, Inc. | 1993-09-08 |
| K925337 | OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT | Olympus Corp. | 1993-01-26 |
| K924246 | ROCHE REAGENT FOR GGT | Roche Diagnostic Systems, Inc. | 1992-11-18 |
| K922947 | GAMMA GULTAMYL TRANSFERASE TEST | Em Diagnostic Systems, Inc. | 1992-09-28 |
| K922230 | OLYMPUS GGT REAGENT | Olympus Corp. | 1992-06-25 |
| K914731 | TRACE GAMMA GT-SS REAGENT | Trace Scientific , Ltd. | 1991-11-19 |
| K913024 | ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST | Em Diagnostic Systems, Inc. | 1991-07-26 |
| K905649 | GAMMA-GLUTAMYL TRANSFERASE DETERMINATION | Biochemical Trade, Inc. | 1991-01-30 |
| K905662 | SYSTEMATE GGT (EPOS APPLICATION) #65414 | Em Diagnostic Systems, Inc. | 1991-01-04 |
| K905085 | RAICHEM GGT REAGENT | Reagents Applications, Inc. | 1990-12-20 |
| K905096 | GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138 | Amresco, Inc. | 1990-11-28 |
| K901264 | COULTER GAMMA-GT (GGT) REAGENT | Coulter Corp. | 1990-04-16 |
| K893765 | GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1 | Em Diagnostic Systems, Inc. | 1989-07-20 |
| K890312 | GAMMA-GLUTAMYLTRANSFERASE | American Monitor Corp. | 1989-03-24 |
| K884988 | GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664 | Em Diagnostic Systems, Inc. | 1989-01-13 |
| K881626 | GAMMA-GLUTAMYL TRANSFERASE | Tech-Co, Inc. | 1988-05-27 |
| K881311 | BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST | Biotrol, USA, Inc. | 1988-04-28 |
| K873378 | GAMMA GLUTAMYLTRANSFERASE | Catachem, Inc. | 1987-09-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414628707 | Atellica CH Gamma-Glutamyl Transferse 2 (GGT_2) | Siemens Healthcare Diagnostics Inc. | 2024-02-02 |
| 00630414313382 | Atellica CH Gamma-Glutamyl Transferse 2 (GGT_2) | Siemens Healthcare Diagnostics Inc. | 2024-02-02 |
| 10673486001860 | Teco Diagnostics g-Glutamyl Transferase (GGT) Liquid Reagent Kit TC-Matrix-240 | TECO DIAGNOSTICS | 2023-11-08 |
| 10673486001877 | Teco Diagnostics g-Glutamyl Transferase (GGT) Liquid Reagent Kit TC-Matrix-480 | TECO DIAGNOSTICS | 2023-11-08 |
| 10673486001839 | Teco Diagnostics g-Glutamyl Transferase Reagent Set (Kinetic, Soluble Substrate) | TECO DIAGNOSTICS | 2023-11-06 |
| 10673486001846 | Teco Diagnostics g-Glutamyl Transferase Reagent Set (Kinetic, Soluble Substrate) | TECO DIAGNOSTICS | 2023-11-06 |
| 10673486001853 | Teco Diagnostics g-Glutamyl Transferase (GGT) Liquid Reagent Set (Kinetic) | TECO DIAGNOSTICS | 2023-11-06 |
| 00811727016140 | Pointe GGT Reagent | HORIBA INSTRUMENTS INCORPORATED | 2021-01-30 |
| 04015630916511 | gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz | Roche Diagnostics GmbH | 2021-01-20 |
| 04015630926855 | gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz | Roche Diagnostics GmbH | 2021-01-18 |
| 04015630925018 | gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz | Roche Diagnostics GmbH | 2021-01-18 |
| 00842768015229 | Dimension Vista® Flex® reagent cartridge GGT | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00842768014154 | Dimension® Flex® reagent cartridge GGT | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 03610230006993 | Yumizen C1200 GGT | HORIBA ABX SAS | 2020-08-31 |
| 00811727015839 | Pointe GGT on BS480 | HORIBA INSTRUMENTS INCORPORATED | 2020-05-28 |
| 10758750004638 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2020-04-18 |
| 07613336121252 | Gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz | Roche Diagnostics GmbH | 2020-03-10 |
| 05060500091880 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | 2017-02-28 |
| 15099590010171 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 15099590020095 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| EABA40000031 | Piccolo Liver Panel Plus | ABAXIS, INC. | 2016-09-23 |
| EABA40000061 | Piccolo General Chemistry 6 | ABAXIS, INC. | 2016-09-23 |
| EABA40000351 | Piccolo BioChemistry Panel Plus | ABAXIS, INC. | 2016-09-23 |
| EABA40000291 | Piccolo General Chemistry 13 | ABAXIS, INC. | 2016-09-23 |
| 05060500090876 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | 2016-09-20 |
| 05060500090883 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | 2016-09-20 |
| 05060500090890 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | 2016-09-20 |
| 05060500090906 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | 2016-09-20 |
| 05060500090913 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | 2016-09-20 |
| 03610230004937 | ABX PENTRA GGT CP | HORIBA ABX SAS | 2016-08-23 |