The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Amresco E4a Reagent Set.
Device ID | K840868 |
510k Number | K840868 |
Device Name: | AMRESCO E4A REAGENT SET |
Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
Applicant | AMERICAN RESEARCH PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJE |
CFR Regulation Number | 862.2160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-27 |
Decision Date | 1984-05-22 |