510(k) K892645

AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY by Amicon, Inc. — Product Code KJF

K892645 is an FDA 510(k) premarket notification submitted by Amicon, Inc. for the device "AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY". The FDA issued a decision of Substantially Equivalent on June 13, 1989. The device falls under product code KJF (System, Suspension, Cell Culture), a Class I device regulated under 21 CFR 864.2240. Amicon, Inc. has at least 10 other 510(k) clearances on record.