The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Ultrachem Bun-uv-gem Saec Appli.#65080&.
| Device ID | K823402 |
| 510k Number | K823402 |
| Device Name: | ULTRACHEM BUN-UV-GEM SAEC APPLI.#65080& |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | EMD CHEMICALS INC. 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 | 1982-11-15 |
| Decision Date | 1982-12-26 |