Sample preservation solution— 510(k) K212878

Name: FDA 510(k) clearance K212878
Creator: U.S. Food and Drug Administration
Published: 2024-04-08

Substantially Equivalent

Zhejiang Gene Science Co., Ltd.

FDA 510(k) clearance K212878 for Sample preservation solution, Substantially Equivalent on 2024-04-08. Applicant: Zhejiang Gene Science Co., Ltd.. Device class: 2.

Clearance details

Applicant: Zhejiang Gene Science Co., Ltd.
Product code: Code QBD
Device class: Class 2
Regulation: 21 CFR 866.2950
Advisory panel: Microbiology
Date received: 2021-09-09
Decision date: 2024-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shaoxing, 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.