510(k) K251048

Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 by STERIS Corporation — Product Code JOJ

K251048 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118". The FDA issued a decision of Substantially Equivalent on May 2, 2025. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. STERIS Corporation has at least 10 other 510(k) clearances on record.