510(k) K160903

STERRAD 100NX Sterilizer with ALLClearTM Technology by Advanced Sterilization Products — Product Code MLR

K160903 is an FDA 510(k) premarket notification submitted by Advanced Sterilization Products for the device "STERRAD 100NX Sterilizer with ALLClearTM Technology". The FDA issued a decision of Substantially Equivalent on September 26, 2016. The device falls under product code MLR (Sterilizer, Chemical), a Class II device regulated under 21 CFR 880.6860. Advanced Sterilization Products has at least 10 other 510(k) clearances on record.