510(k) K182931

VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag by Steris Corporations — Product Code FRC

K182931 is an FDA 510(k) premarket notification submitted by Steris Corporations for the device "VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag". The FDA issued a decision of Substantially Equivalent on November 20, 2018. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Steris Corporations has at least 6 other 510(k) clearances on record.