K153478 is an FDA 510(k) clearance for the Sydney IVF Gamete Buffer, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by William A. Cook Australia Pty. , Ltd. (Eight Mile Plains, AU). The FDA issued a Cleared decision on August 15, 2016, 257 days after receiving the submission on December 2, 2015. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K153478 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 02, 2015 |
| Decision Date | August 15, 2016 |
| Days to Decision | 257 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 |