510(k) K830002

CAPD COLOR-GUARD SYSTEM PREPKIT by Abbott Laboratories — Product Code FKY

K830002 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "CAPD COLOR-GUARD SYSTEM PREPKIT". The FDA issued a decision of Substantially Equivalent on March 11, 1983. The device falls under product code FKY (Connector, Tubing, Dialysate), a Class II device regulated under 21 CFR 876.5820. Abbott Laboratories has at least 10 other 510(k) clearances on record.