510(k) K250044
Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) by
STERIS Corporation
— Product Code FRC
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 6, 2025
- Date Received
- January 10, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indicator, Biological Sterilization Process
- Device Class
- Class II
- Regulation Number
- 880.2800
- Review Panel
- HO
- Submission Type