510(k) K890563

SPQ(TM) ANTIBODY REAGENT SET II FOR TRF by Atlantic Antibodies — Product Code DDG

K890563 is an FDA 510(k) premarket notification submitted by Atlantic Antibodies for the device "SPQ(TM) ANTIBODY REAGENT SET II FOR TRF". The FDA issued a decision of Substantially Equivalent on March 3, 1989. The device falls under product code DDG (Transferrin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5880. Atlantic Antibodies has at least 10 other 510(k) clearances on record.