The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Amresco Calcium Reagent Set.
Device ID | K852657 |
510k Number | K852657 |
Device Name: | AMRESCO CALCIUM REAGENT SET |
Classification | Cresolphthalein Complexone, Calcium |
Applicant | AMERICAN RESEARCH PRODUCTS CO. P.O. BOX 21009 South Euclid, OH 44121 |
Contact | Timothy J Belcastro |
Correspondent | Timothy J Belcastro AMERICAN RESEARCH PRODUCTS CO. P.O. BOX 21009 South Euclid, OH 44121 |
Product Code | CIC |
CFR Regulation Number | 862.1145 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-24 |
Decision Date | 1985-07-15 |