510(k) K183300

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack by Steris Corporations — Product Code FRC

K183300 is an FDA 510(k) premarket notification submitted by Steris Corporations for the device "VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack". The FDA issued a decision of Substantially Equivalent on January 3, 2019. 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.