The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Amresco Flow Pac Alkaline Phosphatase Buffer Conce.
Device ID | K852752 |
510k Number | K852752 |
Device Name: | AMRESCO FLOW PAC ALKALINE PHOSPHATASE BUFFER CONCE |
Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
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 | CJE |
CFR Regulation Number | 862.1050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-28 |
Decision Date | 1985-07-23 |