K203771 is an FDA 510(k) clearance for the Urea Nitrogen2. This device is classified as a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II - Special Controls, product code CDQ).
Submitted by Abbott Ireland Diagnostics Division (Longford, IE). The FDA issued a Cleared decision on May 31, 2022, 524 days after receiving the submission on December 23, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1770.
| 510(k) Number | K203771 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2020 |
| Decision Date | May 31, 2022 |
| Days to Decision | 524 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CDQ - Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1770 |