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510(k) K250205

Babio® Virus Transport Kit (Non-inactivating) by Jinan Babio Biotechnology Co., Ltd. — Product Code JSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2025
Date Received
January 24, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Propagating Transport
Device Class
Class I
Regulation Number
866.2390
Review Panel
MI
Submission Type

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