K000309 is an FDA 510(k) clearance for the BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Irvine Scientific Sales Co., Inc. (Santa Ana, US). The FDA issued a Cleared decision on March 13, 2000, 41 days after receiving the submission on February 1, 2000. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K000309 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 01, 2000 |
| Decision Date | March 13, 2000 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQL — Media, Reproductive |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.6180 |