BioTeke Sterile Disposable Virus Sampling Kit— 510(k) K211707

Name: FDA 510(k) clearance K211707
Creator: U.S. Food and Drug Administration
Published: 2022-05-04

Substantially Equivalent

Bioteke Corporation (Wuxi) Co., Ltd.

FDA 510(k) clearance K211707 for BioTeke Sterile Disposable Virus Sampling Kit, Substantially Equivalent on 2022-05-04. Applicant: Bioteke Corporation (Wuxi) Co., Ltd.. Device class: 1.

Clearance details

Applicant: Bioteke Corporation (Wuxi) Co., Ltd.
Product code: Code JSM
Device class: Class 1
Regulation: 21 CFR 866.2390
Advisory panel: Microbiology
Date received: 2021-06-03
Decision date: 2022-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuxi City, CN

Download summary PDF View on FDA.gov ↗

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