510(k) K141238

STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR by Sterilucent, Inc. — Product Code FRC

K141238 is an FDA 510(k) premarket notification submitted by Sterilucent, Inc. for the device "STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR". The FDA issued a decision of Substantially Equivalent on November 3, 2014. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Sterilucent, Inc. has at least 6 other 510(k) clearances on record.