The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Got Isoenzyme Assay Eiken Kit.
Device ID | K802447 |
510k Number | K802447 |
Device Name: | GOT ISOENZYME ASSAY EIKEN KIT |
Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
Applicant | SYN-KIT, 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 | 1980-10-08 |
Decision Date | 1981-04-17 |