510(k) K890561

SPQ(TM) ANTIBODY REAGENT SET II FOR IGM by Atlantic Antibodies — Product Code CFQ

K890561 is an FDA 510(k) premarket notification submitted by Atlantic Antibodies for the device "SPQ(TM) ANTIBODY REAGENT SET II FOR IGM". The FDA issued a decision of Substantially Equivalent on February 23, 1989. The device falls under product code CFQ (Radioimmunoassay, Immunoglobulins (G, A, M)), a Class II device regulated under 21 CFR 866.5510. Atlantic Antibodies has at least 10 other 510(k) clearances on record.