The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Bun Reagent.
| Device ID | K942984 |
| 510k Number | K942984 |
| Device Name: | BUN REAGENT |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Contact | Leonard C Szymowski |
| Correspondent | Leonard C Szymowski AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Product Code | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-20 |
| Decision Date | 1995-03-01 |