510(k) K890415

SPQ(TM) ANTIBODY REAGENT SET II FOR AAT by Atlantic Antibodies — Product Code DEM

K890415 is an FDA 510(k) premarket notification submitted by Atlantic Antibodies for the device "SPQ(TM) ANTIBODY REAGENT SET II FOR AAT". The FDA issued a decision of Substantially Equivalent on February 17, 1989. The device falls under product code DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5130. Atlantic Antibodies has at least 10 other 510(k) clearances on record.