K030441 is an FDA 510(k) clearance for the SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on August 29, 2003, 199 days after receiving the submission on February 11, 2003. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K030441 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 11, 2003 |
| Decision Date | August 29, 2003 |
| Days to Decision | 199 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 |