Babio® Virus Transport Kit (Non-inactivating)— 510(k) K250205

Name: FDA 510(k) clearance K250205
Creator: U.S. Food and Drug Administration
Published: 2025-09-22

Substantially Equivalent

Jinan Babio Biotechnology Co., Ltd.

FDA 510(k) clearance K250205 for Babio® Virus Transport Kit (Non-inactivating), Substantially Equivalent on 2025-09-22. Applicant: Jinan Babio Biotechnology Co., Ltd.. Device class: 1.

Clearance details

Applicant: Jinan Babio Biotechnology Co., Ltd.
Product code: Code JSM
Device class: Class 1
Regulation: 21 CFR 866.2390
Advisory panel: Microbiology
Date received: 2025-01-24
Decision date: 2025-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jinan, CN

Download summary PDF View on FDA.gov ↗

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