510(k) K853851

FRESENIUS DISPOSABLE BLOOD LINES by Seratronics, Inc. — Product Code FJK

K853851 is an FDA 510(k) premarket notification submitted by Seratronics, Inc. for the device "FRESENIUS DISPOSABLE BLOOD LINES". The FDA issued a decision of Substantially Equivalent on November 12, 1985. The device falls under product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve), a Class II device regulated under 21 CFR 876.5820. Seratronics, Inc. has at least 10 other 510(k) clearances on record.