K242107
- 510(k) number
- K242107
- Device name
- CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)
- Applicant
- Casebioscience, Inc. CA
- Product code
- MQL — Media, Reproductive
- Decision date
- 2025-03-21
- Date received
- 2024-07-18
- 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: K242107.pdf
Official FDA record: K242107
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.