FDA 510(k)

BioSci™ 一次性病毒採樣管

K 號：K230035 · 2023-04-05

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

決定日期2023-04-05

產品代碼JSM

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™ Disposable Virus Sampling Tubes 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 2023-04-05 under 510(k) number K230035. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BioSci™ Disposable Virus Sampling Tubes?

BioSci™ Disposable Virus Sampling Tubes is a medical device that received FDA 510(k) clearance on 2023-04-05. The listed applicant is Shenzhen Dakewe Bio-Engineering Co., Ltd.. The 510(k) number is K230035.

When did BioSci™ Disposable Virus Sampling Tubes receive FDA 510(k) clearance?

BioSci™ Disposable Virus Sampling Tubes received FDA 510(k) clearance on 2023-04-05, under 510(k) number K230035.

Who is the listed applicant for BioSci™ Disposable Virus Sampling Tubes?

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™ Disposable Virus Sampling Tubes?

The FDA product code for BioSci™ Disposable Virus Sampling Tubes is JSM.

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

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相關器械（代碼：JSM）

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。

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官方來源

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