510(k) K844512

DART DAILY AIR REMOVAL TEST by American Sterilizer Co. — Product Code JOJ

K844512 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "DART DAILY AIR REMOVAL TEST". The FDA issued a decision of Substantially Equivalent on March 21, 1985. The device falls under product code JOJ (Indicator, Physical/Chemical 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.