BioSci Disposable Virus Sampling Tubes— 510(k) K230035

Name: FDA 510(k) clearance K230035
Creator: U.S. Food and Drug Administration
Published: 2023-04-05

Substantially Equivalent

Shenzhen Dakewe Bio-Engineering Co., Ltd.

FDA 510(k) clearance K230035 for BioSci Disposable Virus Sampling Tubes, Substantially Equivalent on 2023-04-05. Applicant: Shenzhen Dakewe Bio-Engineering Co., Ltd.. Device class: 1.

Clearance details

Applicant: Shenzhen Dakewe Bio-Engineering Co., Ltd.
Product code: Code JSM
Device class: Class 1
Regulation: 21 CFR 866.2390
Advisory panel: Microbiology
Date received: 2023-01-05
Decision date: 2023-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.