K251122
- 510(k) number
- K251122
- Device name
- Terragene® Bionova® BT20 Biological Indicator
- Applicant
- Terragene AR
- Product code
- FRC — Indicator, Biological Sterilization Process
- Decision date
- 2025-08-04
- Date received
- 2025-04-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K251122.pdf
Official FDA record: K251122
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.