The following data is part of a premarket notification filed by American Scientific Products with the FDA for Urea Nitrogen-bun-reagents B6370-11a.
| Device ID | K831626 |
| 510k Number | K831626 |
| Device Name: | UREA NITROGEN-BUN-REAGENTS B6370-11A |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | AMERICAN SCIENTIFIC PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-20 |
| Decision Date | 1983-07-07 |