510(k) clearance
Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)
- 510(k) number
- K254261
- Applicant
- CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.
- Decision date
- Aug 28, 2026
- Date received
- Dec 30, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- MQL
- Device type
- Media, Reproductive
- Device class
- Class II
- Regulation
- 21 CFR 884.6180
- Advisory committee
- Obstetrics/Gynecology
- Statement or summary
- Summary
- Third party
- N
- Location
- Beijing, CN