The following data is part of a premarket notification filed by Gilford Diagnostics with the FDA for Bun Reagent.
| Device ID | K800341 |
| 510k Number | K800341 |
| Device Name: | BUN REAGENT |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | GILFORD DIAGNOSTICS 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 | 1980-02-15 |
| Decision Date | 1980-03-12 |