510(k) K112018

SMART READ EZTEST STEAM by Mesa Laboratories, Inc. — Product Code FRC

K112018 is an FDA 510(k) premarket notification submitted by Mesa Laboratories, Inc. for the device "SMART READ EZTEST STEAM". The FDA issued a decision of Substantially Equivalent on January 30, 2012. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Mesa Laboratories, Inc. has at least 8 other 510(k) clearances on record.