K112413 is an FDA 510(k) clearance for the RI MSC (MIGRATION SEDIMENTATION CHAMBER). This device is classified as a Labware, Assisted Reproduction (Class II - Special Controls, product code MQK).
Submitted by Research Instruments , Ltd. (Falmouth, Cornwall, GB). The FDA issued a Cleared decision on July 13, 2012, 326 days after receiving the submission on August 22, 2011.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6160.
| 510(k) Number | K112413 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2011 |
| Decision Date | July 13, 2012 |
| Days to Decision | 326 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 |