K801565 is an FDA 510(k) clearance for the CYBREX PHENYTOIN..
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 21, 1980, 13 days after receiving the submission on July 8, 1980.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K801565 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 1980 |
| Decision Date | July 21, 1980 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | — |
| Device Class | — |