The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Data-zyme Urea Nitrogen, Colorimetric.
| Device ID | K801727 |
| 510k Number | K801727 |
| Device Name: | DATA-ZYME UREA NITROGEN, COLORIMETRIC |
| Classification | Berthelot Indophenol, Urea Nitrogen |
| Applicant | DATA MEDICAL ASSOCIATES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDL |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-24 |
| Decision Date | 1980-09-09 |