The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Ast/tgo Monoreactif.
Device ID | K872829 |
510k Number | K872829 |
Device Name: | BIOTROL AST/TGO MONOREACTIF |
Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
Applicant | BIOTROL, USA, INC. P.O. BOX 562 Berwyn, PA 19312 |
Contact | Allan C Murphy |
Correspondent | Allan C Murphy BIOTROL, USA, INC. P.O. BOX 562 Berwyn, PA 19312 |
Product Code | CIT |
CFR Regulation Number | 862.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-17 |
Decision Date | 1987-08-13 |