The following data is part of a premarket notification filed by Technostics Intl. with the FDA for Gamma Glutamyl Transpeptidase (kinectic)reagentset.
| Device ID | K855186 |
| 510k Number | K855186 |
| Device Name: | GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET |
| Classification | Colorimetric Method, Gamma-glutamyl Transpeptidase |
| Applicant | TECHNOSTICS INTL. P.O. BOX 94090 Washington, MI 48094 |
| Contact | Susan Renehan |
| Correspondent | Susan Renehan TECHNOSTICS INTL. P.O. BOX 94090 Washington, MI 48094 |
| Product Code | JPZ |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-26 |
| Decision Date | 1986-01-14 |