Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)— 510(k) K254261
Substantially EquivalentCELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.
FDA 510(k) clearance K254261 for Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK), Substantially Equivalent on 2026-08-28. Applicant: CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.. Device class: 2.
Summary
Cell Store (Beijing) Biotechnology's submission covers a Vitrification Freeze Kit (CS-IVF-FK) and a Thawing Kit (CS-IVF-TK). They're filed under product code MQL, reproductive media.
Class II, 21 CFR 884.6180. Obstetrics/Gynecology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
The applicant filed from Beijing, China. FDA's decision, substantially equivalent, came 241 calendar days after receipt (December 30, 2025 to August 28, 2026).
Clearance details
- Applicant
- CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.
- Product code
- Product code MQL
- Device class
- Class 2
- Regulation
- 21 CFR 884.6180
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beijing, CN
Recent devices under product code MQL
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