510(k) K252672
K252672 is an FDA 510(k) premarket notification submitted by Casebioscience, Inc. for the device "CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)". The FDA issued a decision of Substantially Equivalent on February 20, 2026. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Casebioscience, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 20, 2026
- Date Received
- August 25, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Reproductive
- Device Class
- Class II
- Regulation Number
- 884.6180
- Review Panel
- OB
- Submission Type