The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Durazyme Urea Nitrogen.
| Device ID | K852292 |
| 510k Number | K852292 |
| Device Name: | DURAZYME UREA NITROGEN |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
| Contact | Linda M Chinn |
| Correspondent | Linda M Chinn AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
| Product Code | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-29 |
| Decision Date | 1985-07-08 |