The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Amresco E2a Reagent Set 0562 & 0626.
Device ID | K840887 |
510k Number | K840887 |
Device Name: | AMRESCO E2A REAGENT SET 0562 & 0626 |
Classification | Electrode, Ion Specific, Potassium |
Applicant | AMERICAN RESEARCH PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CEM |
CFR Regulation Number | 862.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-27 |
Decision Date | 1984-04-18 |