The following data is part of a premarket notification filed by Technostics Intl. with the FDA for Glutamic Pyruvic Transaminase, Gpt(uv) Reagent Set.
| Device ID | K860110 |
| 510k Number | K860110 |
| Device Name: | GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET |
| Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
| 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 | CKA |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-13 |
| Decision Date | 1986-02-11 |