FDA 510(k) clearance · back to tracker

Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)

CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD. cleared K254261 on 2026-08-28, decision: substantially equivalent

K-number

K254261

Sponsor

CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.

Device

Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-08-28

Product code

MQL

Advisory committee

Obstetrics/Gynecology

Medical specialty

Obstetrics/Gynecology

Regulation number

884.6180

Official FDA record

Open K254261on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.