510(k) K113221

NAMSA BIOLOGICAL INDICATOR SPORE STRIPS by North American Science Assoc., Inc. — Product Code FRC

K113221 is an FDA 510(k) premarket notification submitted by North American Science Assoc., Inc. for the device "NAMSA BIOLOGICAL INDICATOR SPORE STRIPS". The FDA issued a decision of Substantially Equivalent on April 27, 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.