K250205
- 510(k) number
- K250205
- Device name
- Babio® Virus Transport Kit (Non-inactivating)
- Applicant
- Jinan Babio Biotechnology Co., Ltd. CN
- Product code
- JSM — Culture Media, Non-Propagating Transport
- Decision date
- 2025-09-22
- Date received
- 2025-01-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K250205
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.