510(k) K183295

Celerity HP Chemical Indicator (CI) by Steris Corporations — Product Code JOJ

K183295 is an FDA 510(k) premarket notification submitted by Steris Corporations for the device "Celerity HP Chemical Indicator (CI)". The FDA issued a decision of Substantially Equivalent on January 4, 2019. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Steris Corporations has at least 6 other 510(k) clearances on record.