K853677 is an FDA 510(k) clearance for the TDX REA BUN. 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 September 16, 1985, 12 days after receiving the submission on September 4, 1985.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1770.
| 510(k) Number | K853677 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 1985 |
| Decision Date | September 16, 1985 |
| Days to Decision | 12 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 |