510(k) K211705

3M Attest Rapid Readout Biological Indicator, 1295 by 3M Company — Product Code FRC

K211705 is an FDA 510(k) premarket notification submitted by 3M Company for the device "3M Attest Rapid Readout Biological Indicator, 1295". The FDA issued a decision of Substantially Equivalent on June 28, 2022. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. 3M Company has at least 10 other 510(k) clearances on record.