FDA 510(k)

Female Culture Device; Male Culture Device; Transfer Device; Access Device

Numéro K : K252899 · 2026-06-02

DemandeurZhejiang Kindly Medical Device Co., Ltd.

Date de décision2026-06-02

Code produitJKA

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

Female Culture Device; Male Culture Device; Transfer Device; Access Device is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Kindly Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2026-06-02 under 510(k) number K252899. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Female Culture Device; Male Culture Device; Transfer Device; Access Device?

Female Culture Device; Male Culture Device; Transfer Device; Access Device is a medical device that received FDA 510(k) clearance on 2026-06-02. The listed applicant is Zhejiang Kindly Medical Device Co., Ltd.. The 510(k) number is K252899.

When did Female Culture Device; Male Culture Device; Transfer Device; Access Device receive FDA 510(k) clearance?

Female Culture Device; Male Culture Device; Transfer Device; Access Device received FDA 510(k) clearance on 2026-06-02, under 510(k) number K252899.

Who is the listed applicant for Female Culture Device; Male Culture Device; Transfer Device; Access Device?

The FDA 510(k) record lists Zhejiang Kindly Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Female Culture Device; Male Culture Device; Transfer Device; Access Device?

The FDA product code for Female Culture Device; Male Culture Device; Transfer Device; Access Device is JKA.

Essais cliniques associés

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Source officielle

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