510(k) K150645

AN1087 Dosimeter by Andersen Sterilizers, Inc. — Product Code JOJ

K150645 is an FDA 510(k) premarket notification submitted by Andersen Sterilizers, Inc. for the device "AN1087 Dosimeter". The FDA issued a decision of Substantially Equivalent on November 19, 2015. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Andersen Sterilizers, Inc. has at least 10 other 510(k) clearances on record.