510(k) K091284

VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA by Affinity Biologicals, Inc. — Product Code GGN

K091284 is an FDA 510(k) premarket notification submitted by Affinity Biologicals, Inc. for the device "VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA". The FDA issued a decision of Substantially Equivalent on October 28, 2009. 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.