K250044

Substantially Equivalent

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
Product code: FRC
Advisory panel: General Hospital
Date received: 2025-01-10
Decision date: 2025-02-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.