The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Liquizyme Chloride Reagent.
Device ID | K820411 |
510k Number | K820411 |
Device Name: | LIQUIZYME CHLORIDE REAGENT |
Classification | Coulometric, Chloride |
Applicant | AMERICAN RESEARCH PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JFS |
CFR Regulation Number | 862.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-02-12 |
Decision Date | 1982-03-08 |