The following data is part of a premarket notification filed by Derma Media Lab., Inc. with the FDA for Ast/sgot.
Device ID | K965126 |
510k Number | K965126 |
Device Name: | AST/SGOT |
Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
Applicant | DERMA MEDIA LAB., INC. 8531 WELLSFORD PL., SUITE E Santa Fe Springs, CA 90670 |
Contact | Charles C Allain, Ph.d. |
Correspondent | Charles C Allain, Ph.d. DERMA MEDIA LAB., INC. 8531 WELLSFORD PL., SUITE E Santa Fe Springs, CA 90670 |
Product Code | CIT |
CFR Regulation Number | 862.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-12-23 |
Decision Date | 1997-01-17 |