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FDA 510(k)

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

K 號:K252899 · 2026-06-02

決定日期2026-06-02
產品代碼JKA
諮詢委員會CH
決定Substantially Equivalent

器材摘要

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.

常見問題

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.

相關臨床試驗

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其他以 Zhejiang Kindly Medical Device Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

相關器械(代碼:JKA)

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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