K023850 is an FDA 510(k) clearance for the SYDNEY IVF EMBRYO BIOPSY MEDIUM, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on January 22, 2003, 64 days after receiving the submission on November 19, 2002. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K023850 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 19, 2002 |
| Decision Date | January 22, 2003 |
| Days to Decision | 64 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 |