K150961 is an FDA 510(k) clearance for the EmbryoSlide Culture Dish, a Labware, Assisted Reproduction (Class II — Special Controls, product code MQK), submitted by Vitrolife A/S (Viby J, DK). The FDA issued a Cleared decision on December 4, 2015, 238 days after receiving the submission on April 10, 2015. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6160.
| 510(k) Number | K150961 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 10, 2015 |
| Decision Date | December 04, 2015 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQK — Labware, Assisted Reproduction |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.6160 |