The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Flow-pac Urea Nitrogen Reagent Set 2214, 2814.
| Device ID | K871320 |
| 510k Number | K871320 |
| Device Name: | FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814 |
| Classification | Diacetyl-monoxime, Urea Nitrogen |
| Applicant | AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Contact | J. A Levey |
| Correspondent | J. A Levey 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 | 1987-04-03 |
| Decision Date | 1987-04-22 |