The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Urea.
| Device ID | K981123 |
| 510k Number | K981123 |
| Device Name: | UREA |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | TRACE SCIENTIFIC LTD. 189-199 BROWNS RD. NOBLE PARK Victoria, AU 3174 |
| Product Code | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-27 |
| Decision Date | 1998-04-24 |
| Summary: | summary |