Disposable Sampler Inactivated Transport Media, Nest ITM— 510(k) K210440

Name: FDA 510(k) clearance K210440
Creator: U.S. Food and Drug Administration
Published: 2021-09-20

Substantially Equivalent

Wuxi Nest Biotechnology Co., Ltd.

FDA 510(k) clearance K210440 for Disposable Sampler Inactivated Transport Media, Nest ITM, Substantially Equivalent on 2021-09-20. Applicant: Wuxi Nest Biotechnology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Wuxi Nest Biotechnology Co., Ltd.
Product code: Code QBD
Device class: Class 2
Regulation: 21 CFR 866.2950
Advisory panel: Microbiology
Date received: 2021-02-12
Decision date: 2021-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuxi, 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.