K133912 is an FDA 510(k) clearance for the ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO. This device is classified as a Media, Reproductive (Class II - Special Controls, product code MQL).
Submitted by Origio A/S (Maaloev, DK). The FDA issued a Cleared decision on May 14, 2014, 142 days after receiving the submission on December 23, 2013.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K133912 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2013 |
| Decision Date | May 14, 2014 |
| Days to Decision | 142 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 |