510(k) K113302

NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS by North American Science Assoc., Inc. — Product Code FRC

K113302 is an FDA 510(k) premarket notification submitted by North American Science Assoc., Inc. for the device "NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS". The FDA issued a decision of Substantially Equivalent on January 20, 2012. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. North American Science Assoc., Inc. has at least 5 other 510(k) clearances on record.