510(k) K852310

NATURALYTE BICARBONATE CONCENTRATE-DRY PACK by Erika, Inc. — Product Code FKQ

K852310 is an FDA 510(k) premarket notification submitted by Erika, Inc. for the device "NATURALYTE BICARBONATE CONCENTRATE-DRY PACK". The FDA issued a decision of Substantially Equivalent on July 26, 1985. 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.