510(k) K890562

SPQ(TM) ANTIBODY REAGENT SET II FOR HPT by Atlantic Antibodies — Product Code DAD

K890562 is an FDA 510(k) premarket notification submitted by Atlantic Antibodies for the device "SPQ(TM) ANTIBODY REAGENT SET II FOR HPT". The FDA issued a decision of Substantially Equivalent on February 22, 1989. The device falls under product code DAD (Haptoglobin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5460. Atlantic Antibodies has at least 10 other 510(k) clearances on record.