The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Gemeni Ast-lts Reagents.
| Device ID | K851267 |
| 510k Number | K851267 |
| Device Name: | GEMENI AST-LTS REAGENTS |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 |
| Contact | La Brec |
| Correspondent | La Brec ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 |
| Product Code | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-29 |
| Decision Date | 1985-04-29 |