K040761 is an FDA 510(k) clearance for the AXSYM CYCLOSPORINE. This device is classified as a Cyclosporine (Class II - Special Controls, product code MKW).
Submitted by Abbott Laboratories, Inc. (Abbott Park, US). The FDA issued a Cleared decision on April 30, 2004, 36 days after receiving the submission on March 25, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1235.
| 510(k) Number | K040761 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2004 |
| Decision Date | April 30, 2004 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MKW — Cyclosporine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1235 |