510(k) K855186
- Device
- GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET
- Applicant
- TECHNOSTICS INTL.
- 510(k) number
- K855186
- Product code
- JPZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-01-14
- Date received
- 1985-12-26
- Regulation
- 862.1360
- Classification name
- Colorimetric Method, Gamma-glutamyl Transpeptidase
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SUSAN RENEHAN
- Address
- P.O. Box 94090 Washington MI US 48094 48094
FDA Registration Numbers#
- 3005094123
- 9610126
- 2432235
- 3004493545
- 1220972
- 3002809144
- 3016438761
- 2030861
- 2050010
- 1181121
- 2085064
- 1000403749
- 2050012
- 3006716639
- 2247288
- 3005333358
- 3003741796
- 3014325803
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JPZ #
| 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 |
Legacy Summary#
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FDA Review#
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