FDA 510(k)

Biosci™ 無活性傳送培養基，Biosci™ ITM

K 號：K220059 · 2023-01-19

申請人Shenzhen Dakewe Bio-Engineering Co., Ltd.

決定日期2023-01-19

產品代碼QBD

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

Biosci™ Inactivated Transport Medium, Biosci™ ITM is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dakewe Bio-Engineering Co., Ltd.. It received FDA 510(k) clearance on 2023-01-19 under 510(k) number K220059. The device is classified under product code QBD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Biosci™ Inactivated Transport Medium, Biosci™ ITM?

Biosci™ Inactivated Transport Medium, Biosci™ ITM is a medical device that received FDA 510(k) clearance on 2023-01-19. The listed applicant is Shenzhen Dakewe Bio-Engineering Co., Ltd.. The 510(k) number is K220059.

When did Biosci™ Inactivated Transport Medium, Biosci™ ITM receive FDA 510(k) clearance?

Biosci™ Inactivated Transport Medium, Biosci™ ITM received FDA 510(k) clearance on 2023-01-19, under 510(k) number K220059.

Who is the listed applicant for Biosci™ Inactivated Transport Medium, Biosci™ ITM?

The FDA 510(k) record lists Shenzhen Dakewe Bio-Engineering Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biosci™ Inactivated Transport Medium, Biosci™ ITM?

The FDA product code for Biosci™ Inactivated Transport Medium, Biosci™ ITM is QBD.

其他以 Shenzhen Dakewe Bio-Engineering Co., Ltd. 為申請人之記錄

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官方來源

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