Kinetic Method, Gamma-Glutamyl Transpeptidase
FDA product code JQB · Class I (low risk) · 21 CFR 862.1360 · Clinical Chemistry
52510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Em Diagnostic Systems, Inc. 10
- Emd Chemicals, Inc. 3
- Olympus Corp. 2
- Sclavo, Inc. 2
- American Monitor Corp. 2
- Pointe Scientific, Inc., 2
- Harleco 2
- Roche Diagnostic Systems, Inc. 2
- Diagnostic Chemicals , Ltd. 2
- Sigma Diagnostics, Inc. 2
- Coulter Electronics, Inc. 1
- Coulter Corp. 1
- Tech-Co, Inc. 1
- Catachem, Inc. 1
- Alpkem Corp. 1
- Data Medical Associates, Inc. 1
- Technicon Instruments Corp. 1
- Carolina Liquid Chemistries Corp. 1
- American Dade 1
- Warm & Form, Orthopedic Materials 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974000 | Y-Glutamyltransferase-Sl Assay , Cataloge Number 324-10, 324-30JQB · Traditional | Diagnostic Chemicals , Ltd. | 11/04/1997SE |
| K973157 | Liquid GGT (Gamma Glutamyl Transferase) Reagent SetJQB · Traditional | Pointe Scientific, Inc., | 10/10/1997SE |
| K971466 | Synchron CX Systems Gamma-Glutamyl Transferase Reagent (GGT)JQB · Traditional | Carolina Liquid Chemistries Corp. | 05/06/1997SE |
| K964457 | Roche Cobas Ibtegra Reagent CassettesJQB · Traditional | Roche Diagnostic Systems, Inc. | 01/13/1997SE |
| K964916 | Gamma-Glutamyl TranspeptidaseJQB · Traditional | Derma Media Lab., Inc. | 01/10/1997SE |
| K955770 | Gamma Glutamyl Transferase Test SystemJQB · Traditional | Abaxis, Inc. | 09/09/1996SE |
| K945800 | Y-Glutamyltransferase Assay, Catalogue Number 308-05JQB · Traditional | Diagnostic Chemicals , Ltd. | 06/09/1995SE |
| K946192 | Hichem Y-Gt Reagent KitJQB · Traditional | Hichem Diagnostics | 05/02/1995SE |
| K942962 | GGT QvetJQB · Traditional | Prisma Systems | 12/07/1994SE |
| K935984 | Glutamyl-Transferase, Procedure No. 419JQB · Traditional | Sigma Diagnostics, Inc. | 07/20/1994SE |
| K941315 | Stanbio Y-Gt (Liquicolor) Test SetJQB · Traditional | Stanbio Laboratory | 07/14/1994SE |
| K935177 | Gamma-Glutamyl Transferase (GGT) TestJQB · Traditional | Em Diagnostic Systems, Inc. | 12/16/1993SE |
| K931958 | Synermed GGT Reagent KitJQB · Traditional | Synermed, Inc. | 09/08/1993SE |
| K925337 | Olympus Gamma Glutamyl Transferase ReagentJQB · Traditional | Olympus Corp. | 01/26/1993SE |
| K924246 | Roche Reagent for GGTJQB · Traditional | Roche Diagnostic Systems, Inc. | 11/18/1992SE |
| K922947 | Gamma Gultamyl Transferase TestJQB · Traditional | Em Diagnostic Systems, Inc. | 09/28/1992SE |
| K922230 | Olympus GGT ReagentJQB · Traditional | Olympus Corp. | 06/25/1992SE |
| K914731 | Trace Gamma Gt-Ss ReagentJQB · Traditional | Trace Scientific , Ltd. | 11/19/1991SE |
| K913024 | Abbott Quickstart Gamma-Glutamytransferase TestJQB · Traditional | Em Diagnostic Systems, Inc. | 07/26/1991SE |
| K905649 | Gamma-Glutamyl Transferase DeterminationJQB · Traditional | Biochemical Trade, Inc. | 01/30/1991SE |
| K905662 | Systemate GGT (Epos Application) #65414JQB · Traditional | Em Diagnostic Systems, Inc. | 01/04/1991SE |
| K905085 | Raichem GGT ReagentJQB · Traditional | Reagents Applications, Inc. | 12/20/1990SE |
| K905096 | GGT Reagents, 7738, 7739, 7538, 7438 & 7138JQB · Traditional | Amresco, Inc. | 11/28/1990SE |
| K901264 | Coulter Gamma-Gt (GGT) ReagentJQB · Traditional | Coulter Corp. | 04/16/1990SE |
| K893765 | Gamma Glutamyl Transferase Test, Item: 65414/R1JQB · Traditional | Em Diagnostic Systems, Inc. | 07/20/1989SE |
| K890312 | Gamma-GlutamyltransferaseJQB · Traditional | American Monitor Corp. | 03/24/1989SE |
| K884988 | Gamma Glutamyl Transferase Test (GGT) Item: 65664JQB · Traditional | Em Diagnostic Systems, Inc. | 01/13/1989SE |
| K881626 | Gamma-Glutamyl TransferaseJQB · Traditional | Tech-Co, Inc. | 05/27/1988SE |
| K881311 | Biotrol -Gt Gamma-Glutamyl Transferase (GGT) TestJQB · Traditional | Biotrol, USA, Inc. | 04/28/1988SE |
| K873378 | Gamma GlutamyltransferaseJQB · Traditional | Catachem, Inc. | 09/08/1987SE |
| K873135 | Unifast Gamma-GtJQB · Traditional | Sclavo, Inc. | 09/04/1987SE |
| K872322 | Emds Gamma-Glutamyl Transferase (GGT) 67680/95JQB · Traditional | Em Diagnostic Systems, Inc. | 07/27/1987SE |
| K872320 | Easy-Test Gamma-Glutamyl Transferase (GGT) 16616JQB · Traditional | Em Diagnostic Systems, Inc. | 07/27/1987SE |
| K860640 | Easy-Test (GGT) Reagent, Item No. 67526/93JQB · Traditional | Em Diagnostic Systems, Inc. | 04/09/1986SE |
| K851999 | G-Gt ReagentJQB · Traditional | Alpkem Corp. | 06/10/1985SE |
| K850319 | Y-Glutamyltransferase(Y-Gt) ReagentJQB · Traditional | Sigma Diagnostics, Inc. | 02/12/1985SE |
| K844720 | GGT Procedure or Gamma Glutamyl Transferase ProcedJQB · Traditional | Data Medical Associates, Inc. | 12/12/1984SE |
| K843268 | Systemate 2GT - 67207JQB · Traditional | Em Diagnostic Systems, Inc. | 09/13/1984SE |
| K834054 | Dart Gamma-Gt Reagent SystemJQB · Traditional | Coulter Electronics, Inc. | 02/04/1984SE |
| K833029 | Flow-Pac GGT Reagent SetJQB · Traditional | American Research Products Co. | 12/29/1983SE |
| K833001 | Paramax & Glutamytransferase ReagentJQB · Traditional | American Dade | 10/14/1983SE |
| K830308 | Ultra Zyme Plus Gamma GT #65055 & 56JQB · Traditional | Emd Chemicals, Inc. | 02/28/1983SE |
| K830246 | Cast Shoe, Cast BootJQB · Traditional | Warm & Form, Orthopedic Materials | 02/18/1983SE |
| K830240 | Ultrazyme Plus Gamma Gt-Mca #65055-65056JQB · Traditional | Emd Chemicals, Inc. | 02/18/1983SE |
| K823883 | Ultrazyme Plus Gamma-Gt, #64959/65032JQB · Traditional | Emd Chemicals, Inc. | 01/28/1983SE |
| K820233 | Ultrazyme Plus Gamma GT(65055-65056)JQB · Traditional | Harleco | 02/12/1982SE |
| K813041 | Ultrazyme-Gt, Item #64959 & 65032JQB · Traditional | Harleco | 11/10/1981SE |
| K812296 | Gamma Glutamy TranspeptidaseJQB · Traditional | Pointe Scientific, Inc., | 08/31/1981SE |
| K810434 | Gamma-Gt Reagent SystemJQB · Traditional | American Monitor Corp. | 02/26/1981SE |
| K800769 | Y-Gt Test, Y-Glutamyl Transferase TestJQB · Traditional | Sclavo, Inc. | 04/24/1980SE |
| K780071 | Gama-Gpt Reagent SetJQB · Traditional | Medical Analysis Systems, Inc. | 02/14/1978SE |
| K761090 | Diagnostic METHOD-8-GLUTAMYLTRANSFERASEJQB · Traditional | Technicon Instruments Corp. | 12/02/1976SE |