K090832 is an FDA 510(k) clearance for the RAPID-I. This device is classified as a Labware, Assisted Reproduction (Class II - Special Controls, product code MQK).
Submitted by Vitrolife Sweden AB (Se-400 92 Goteborg, SE). The FDA issued a Cleared decision on December 23, 2009, 272 days after receiving the submission on March 26, 2009.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6160.
| 510(k) Number | K090832 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2009 |
| Decision Date | December 23, 2009 |
| Days to Decision | 272 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 |