K254261
- 510(k) number
- K254261
- Device name
- Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)
- Applicant
- CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD. CN
- Product code
- MQL — Media, Reproductive
- Decision date
- 2026-08-28
- Date received
- 2025-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K254261.pdf
Official FDA record: K254261
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.