K250044
- 510(k) number
- K250044
- Device name
- Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)
- Applicant
- STERIS Corporation OH · US
- Product code
- FRC — Indicator, Biological Sterilization Process
- Decision date
- 2025-02-06
- Date received
- 2025-01-10
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250044.pdf
Official FDA record: K250044
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.