K080751 is an FDA 510(k) clearance for the ARCHITECT CYCLOSPORINE. This device is classified as a Cyclosporine (Class II - Special Controls, product code MKW).
Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on September 11, 2008, 177 days after receiving the submission on March 18, 2008.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1235.
| 510(k) Number | K080751 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 2008 |
| Decision Date | September 11, 2008 |
| Days to Decision | 177 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | MKW — Cyclosporine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1235 |