510(k) K890416

SPQ(TM) ANTIBODY REAGENT SET II FOR IGG by Atlantic Antibodies — Product Code DEW

K890416 is an FDA 510(k) premarket notification submitted by Atlantic Antibodies for the device "SPQ(TM) ANTIBODY REAGENT SET II FOR IGG". The FDA issued a decision of Substantially Equivalent on February 22, 1989. The device falls under product code DEW (Igg, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Atlantic Antibodies has at least 10 other 510(k) clearances on record.