Sample Preservative Fluid— 510(k) K222771

Name: FDA 510(k) clearance K222771
Creator: U.S. Food and Drug Administration
Published: 2024-06-26

Substantially Equivalent

Hangzhou Bioer Technology Co., Ltd.

FDA 510(k) clearance K222771 for Sample Preservative Fluid, Substantially Equivalent on 2024-06-26. Applicant: Hangzhou Bioer Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hangzhou Bioer Technology Co., Ltd.
Product code: Code QBD
Device class: Class 2
Regulation: 21 CFR 866.2950
Advisory panel: Microbiology
Date received: 2022-09-14
Decision date: 2024-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, 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.