The following data is part of a premarket notification filed by Harleco Diagnostics with the FDA for Ultrachem Bun-uv, 65080 & 65081.
| Device ID | K822323 |
| 510k Number | K822323 |
| Device Name: | ULTRACHEM BUN-UV, 65080 & 65081 |
| Classification | Diacetyl-monoxime, Urea Nitrogen |
| Applicant | HARLECO DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDW |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-03 |
| Decision Date | 1982-09-02 |