510(k) K151585

Andersen EOGas 4 SteriTest by Andersen Sterilizers, Inc. — Product Code FRC

K151585 is an FDA 510(k) premarket notification submitted by Andersen Sterilizers, Inc. for the device "Andersen EOGas 4 SteriTest". The FDA issued a decision of Substantially Equivalent on November 18, 2015. The device falls under product code FRC (Indicator, Biological 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.