The following data is part of a premarket notification filed by Medical Specialties, Inc. with the FDA for Sgot Reagent Set.
Device ID | K841065 |
510k Number | K841065 |
Device Name: | SGOT REAGENT SET |
Classification | Diazo, Ast/sgot |
Applicant | MEDICAL SPECIALTIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CIQ |
CFR Regulation Number | 862.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-12 |
Decision Date | 1984-05-01 |