The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Urea.
| Device ID | K981918 |
| 510k Number | K981918 |
| Device Name: | UREA |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | ABBOTT LABORATORIES DEPT. 09VA LC-2 1920 HURD DRIVE Irving, TX 75038 |
| Contact | Mark Littlefield |
| Correspondent | Mark Littlefield ABBOTT LABORATORIES DEPT. 09VA LC-2 1920 HURD DRIVE Irving, TX 75038 |
| Product Code | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-01 |
| Decision Date | 1998-07-28 |
| Summary: | summary |