Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)— 510(k) K254261

Name: FDA 510(k) clearance K254261
Creator: U.S. Food and Drug Administration
Published: 2026-08-28

Substantially Equivalent

CELL 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.

Clearance details

Applicant: CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2025-12-30
Decision date: 2026-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQL

view all

K260248 — Ultra-Fast Warm2026-04-28
K252672 — CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)2026-02-20
K250445 — Fast Warm - NX2025-09-12
K251637 — Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA] +1 more2025-08-27
K251305 — Ultra-Fast Vitri; Ultra-Fast Warm2025-08-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.