The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Seralyzer Ast/sgot Reagent Strips.
Device ID | K832790 |
510k Number | K832790 |
Device Name: | SERALYZER AST/SGOT REAGENT STRIPS |
Classification | Vanillin Pyruvate, Ast/sgot |
Applicant | MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CIF |
CFR Regulation Number | 862.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-16 |
Decision Date | 1983-10-14 |