The following data is part of a premarket notification filed by Macomb Chemical Co. with the FDA for Enzymatic Urea Nitrogen Reagent Set Revi.
| Device ID | K800719 |
| 510k Number | K800719 |
| Device Name: | ENZYMATIC UREA NITROGEN REAGENT SET REVI |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | MACOMB CHEMICAL CO. 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 | 1980-03-31 |
| Decision Date | 1980-05-08 |