FDA 510(k)

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

Número K: K252899 · 2026-06-02

RequerenteZhejiang Kindly Medical Device Co., Ltd.

Data da decisão2026-06-02

Código do produtoJKA

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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