The following data is part of a premarket notification filed by J. D. Assoc. with the FDA for Ast S.c.e. (got).
Device ID | K863054 |
510k Number | K863054 |
Device Name: | AST S.C.E. (GOT) |
Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
Applicant | J. D. ASSOC. 163 MONTCLAIR AVE. Montclair, NJ 07042 |
Contact | Di Pietro |
Correspondent | Di Pietro J. D. ASSOC. 163 MONTCLAIR AVE. Montclair, NJ 07042 |
Product Code | CIT |
CFR Regulation Number | 862.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-08-12 |
Decision Date | 1987-01-13 |