K810794 is an FDA 510(k) clearance for the A-GENT UREA NITROGEN. This device is classified as a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II - Special Controls, product code CDQ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 1, 1981, 9 days after receiving the submission on March 23, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1770.
| 510(k) Number | K810794 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 1981 |
| Decision Date | April 01, 1981 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CDQ — Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1770 |