510(k) K141580

STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR by Tso3, Inc. — Product Code FRC

K141580 is an FDA 510(k) premarket notification submitted by Tso3, Inc. for the device "STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR". The FDA issued a decision of Substantially Equivalent on December 17, 2014. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Tso3, Inc. has at least 9 other 510(k) clearances on record.