K200815 is an FDA 510(k) clearance for the VitriGuard. This device is classified as a Labware, Assisted Reproduction (Class II - Special Controls, product code MQK).
Submitted by Origio A/S (Måløv, DK). The FDA issued a Cleared decision on June 25, 2020, 87 days after receiving the submission on March 30, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6160.
| 510(k) Number | K200815 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2020 |
| Decision Date | June 25, 2020 |
| Days to Decision | 87 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 |