The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Bun (urease) Reagent.
| Device ID | K781253 |
| 510k Number | K781253 |
| Device Name: | BUN (UREASE) REAGENT |
| Classification | Urease, Photometric, Urea Nitrogen |
| Applicant | COULTER ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDN |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-07-21 |
| Decision Date | 1978-08-21 |