510(k) K822485

HPF 100,200,300 CAPILLARY FLOW DIALYZ by Erika, Inc. — Product Code FKQ

K822485 is an FDA 510(k) premarket notification submitted by Erika, Inc. for the device "HPF 100,200,300 CAPILLARY FLOW DIALYZ". The FDA issued a decision of Substantially Equivalent on August 30, 1982. The device falls under product code FKQ (System, Dialysate Delivery, Central Multiple Patient), a Class II device regulated under 21 CFR 876.5820. Erika, Inc. has at least 10 other 510(k) clearances on record.