510(k) K141244

NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES) by North American Science Assoc., Inc. — Product Code FRC

K141244 is an FDA 510(k) premarket notification submitted by North American Science Assoc., Inc. for the device "NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES)". The FDA issued a decision of Substantially Equivalent on September 9, 2014. 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.