Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)— 510(k) K251452

Substantially Equivalent

Steris

FDA 510(k) clearance K251452 for Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045), Substantially Equivalent on 2025-06-06. Applicant: Steris.

Clearance details

Applicant
Steris
Product code
Code FRC
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Mentor, OH, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.