510(k) K183294

CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack by STERIS Corporation — Product Code FRC

K183294 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack". The FDA issued a decision of Substantially Equivalent on Jan 3, 2019. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. STERIS Corporation has 204 other 510(k) clearances on record.