The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Ast(got) Uni-uv, Sgot.
Device ID | K780463 |
510k Number | K780463 |
Device Name: | AST(GOT) UNI-UV, SGOT |
Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
Applicant | SCLAVO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CIT |
CFR Regulation Number | 862.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-03-23 |
Decision Date | 1978-05-12 |