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 |