The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Amresco Flow Pac Total Iron Reagent Set #1241.
Device ID | K863426 |
510k Number | K863426 |
Device Name: | AMRESCO FLOW PAC TOTAL IRON REAGENT SET #1241 |
Classification | Ferrozine (colorimetric) Iron Binding Capacity |
Applicant | AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
Contact | Timothy J Belcastro |
Correspondent | Timothy J Belcastro AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
Product Code | JMO |
CFR Regulation Number | 862.1415 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-04 |
Decision Date | 1986-09-16 |