The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Flow-pac Chloride Reagent Set.
Device ID | K834333 |
510k Number | K834333 |
Device Name: | FLOW-PAC CHLORIDE REAGENT SET |
Classification | Mercuric Thiocyanate, Colorimetry, Chloride |
Applicant | AMERICAN RESEARCH PRODUCTS CO. 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 | 1983-12-12 |
Decision Date | 1984-02-21 |