510(k) K850144

BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH by American Sterilizer Co. — Product Code FRC

K850144 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH". The FDA issued a decision of Substantially Equivalent on June 17, 1985. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. American Sterilizer Co. has at least 10 other 510(k) clearances on record.