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 |