K252672
- 510(k) number
- K252672
- Device name
- CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)
- Applicant
- Casebioscience, Inc. CA
- Product code
- MQL — Media, Reproductive
- Decision date
- 2026-02-20
- Date received
- 2025-08-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K252672.pdf
Official FDA record: K252672
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.