The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Stattek Bun.
| Device ID | K792328 |
| 510k Number | K792328 |
| Device Name: | STATTEK BUN |
| Classification | Urease, Photometric, Urea Nitrogen |
| Applicant | BOEHRINGER MANNHEIM CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CDN |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-19 |
| Decision Date | 1979-12-18 |