FDA 510(k)

生物特克无菌一次性病毒採樣套件

K 號：K211707 · 2022-05-04

決定日期2022-05-04

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

BioTeke Sterile Disposable Virus Sampling Kit is the device name listed in this FDA 510(k) record. The listed applicant is Bioteke Corporation (Wuxi) Co., Ltd.. It received FDA 510(k) clearance on 2022-05-04 under 510(k) number K211707. 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 BioTeke Sterile Disposable Virus Sampling Kit?

BioTeke Sterile Disposable Virus Sampling Kit is a medical device that received FDA 510(k) clearance on 2022-05-04. The listed applicant is Bioteke Corporation (Wuxi) Co., Ltd.. The 510(k) number is K211707.

When did BioTeke Sterile Disposable Virus Sampling Kit receive FDA 510(k) clearance?

BioTeke Sterile Disposable Virus Sampling Kit received FDA 510(k) clearance on 2022-05-04, under 510(k) number K211707.

Who is the listed applicant for BioTeke Sterile Disposable Virus Sampling Kit?

FDA 510(k) 記錄將Bioteke Corporation (Wuxi) Co., Ltd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for BioTeke Sterile Disposable Virus Sampling Kit?

The FDA product code for BioTeke Sterile Disposable Virus Sampling Kit is JSM.

其他以 Bioteke Corporation (Wuxi) 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。

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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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