510(k) K964728

STA-LIATEST D-DI TEST KIT by American Bioproducts Co. — Product Code DAP

K964728 is an FDA 510(k) premarket notification submitted by American Bioproducts Co. for the device "STA-LIATEST D-DI TEST KIT". The FDA issued a decision of Substantially Equivalent on Jun 26, 1997. The device falls under product code DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 864.7320. American Bioproducts Co. has 78 other 510(k) clearances on record.