Cleared Traditional

Babio? Virus Transport Kit (Non-inactivating)

K250205 · Jinan Babio Biotechnology Co., Ltd. · Microbiology

Sep 2025

Decision

241d

Days

Class 1

Risk

About This 510(k) Submission

K250205 is an FDA 510(k) clearance for the Babio? Virus Transport Kit (Non-inactivating), a Culture Media, Non-propagating Transport (Class I — General Controls, product code JSM), submitted by Jinan Babio Biotechnology Co., Ltd. (Jinan, CN). The FDA issued a Cleared decision on September 22, 2025, 241 days after receiving the submission on January 24, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number	K250205 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 24, 2025
Decision Date	September 22, 2025
Days to Decision	241 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement