510(k) K881062

CENTRY 2 ULTRAFILTRATION CONTROL KIT, #018762-002 by Cobe Laboratories, Inc. — Product Code FJB

K881062 is an FDA 510(k) premarket notification submitted by Cobe Laboratories, Inc. for the device "CENTRY 2 ULTRAFILTRATION CONTROL KIT, #018762-002". The FDA issued a decision of Substantially Equivalent on April 21, 1988. The device falls under product code FJB (Detector, Dialysate Level), a Class II device regulated under 21 CFR 876.5820. Cobe Laboratories, Inc. has at least 10 other 510(k) clearances on record.