510(k) K250205
K250205 is an FDA 510(k) premarket notification submitted by Jinan Babio Biotechnology Co., Ltd. for the device "Babio® Virus Transport Kit (Non-inactivating)". The FDA issued a decision of Substantially Equivalent on September 22, 2025. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390.
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