The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Dart Urea Nitrogen.
| Device ID | K894836 |
| 510k Number | K894836 |
| Device Name: | DART UREA NITROGEN |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | COULTER ELECTRONICS, INC. 745 WEST 83RD ST. Hialeah, FL 33014 |
| Contact | Richardson-jones |
| Correspondent | Richardson-jones COULTER ELECTRONICS, INC. 745 WEST 83RD ST. Hialeah, FL 33014 |
| Product Code | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-31 |
| Decision Date | 1989-10-30 |