The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Amresco Flow Pac Urea Nitrogen Reagents #1346.
| Device ID | K863425 |
| 510k Number | K863425 |
| Device Name: | AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346 |
| Classification | Diacetyl-monoxime, Urea Nitrogen |
| 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 | CDW |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-04 |
| Decision Date | 1986-10-01 |