The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Liquizyme Calcium Reagent Set.
Device ID | K823219 |
510k Number | K823219 |
Device Name: | LIQUIZYME CALCIUM REAGENT SET |
Classification | Cresolphthalein Complexone, Calcium |
Applicant | AMERICAN RESEARCH PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CIC |
CFR Regulation Number | 862.1145 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-28 |
Decision Date | 1982-12-03 |