510(k) K110432

VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN by Affinity Biologicals, Inc. — Product Code GGN

K110432 is an FDA 510(k) premarket notification submitted by Affinity Biologicals, Inc. for the device "VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN". The FDA issued a decision of Substantially Equivalent on October 20, 2011. The device falls under product code GGN (Plasma, Coagulation Control), a Class II device regulated under 21 CFR 864.5425. Affinity Biologicals, Inc. has at least 4 other 510(k) clearances on record.