The following data is part of a premarket notification filed by Amresco, Inc. with the FDA for Chloride Reagent Set.
Device ID | K832438 |
510k Number | K832438 |
Device Name: | CHLORIDE REAGENT SET |
Classification | Mercuric Thiocyanate, Colorimetry, Chloride |
Applicant | AMRESCO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CHJ |
CFR Regulation Number | 862.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-25 |
Decision Date | 1984-01-20 |