510(k) K891154

SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B by Atlantic Antibodies — Product Code MSJ

K891154 is an FDA 510(k) premarket notification submitted by Atlantic Antibodies for the device "SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B". The FDA issued a decision of Substantially Equivalent on March 16, 1989. The device falls under product code MSJ (Apolipoproteins), a Class I device regulated under 21 CFR 862.1475. Atlantic Antibodies has at least 10 other 510(k) clearances on record.