K242107 is an FDA 510(k) clearance for the CaseMONO™ Culture (CMON). This device is classified as a Media, Reproductive (Class II - Special Controls, product code MQL).
Submitted by Casebioscience, Inc. (Guelph, CA). The FDA issued a Cleared decision on March 21, 2025, 246 days after receiving the submission on July 18, 2024.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K242107 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2024 |
| Decision Date | March 21, 2025 |
| Days to Decision | 246 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 |