510(k) K111518

STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 by Advanced Sterilization Products — Product Code JOJ

K111518 is an FDA 510(k) premarket notification submitted by Advanced Sterilization Products for the device "STERRAD CHEMIAL INDICATOR STRIP MODEL 14100". The FDA issued a decision of Substantially Equivalent on October 3, 2012. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Advanced Sterilization Products has at least 10 other 510(k) clearances on record.