510(k) K073042

HEMOSIL D-DIMER by Instrumentation Laboratory — Product Code DAP

K073042 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory for the device "HEMOSIL D-DIMER". The FDA issued a decision of Substantially Equivalent on July 31, 2008. 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. Instrumentation Laboratory has at least 10 other 510(k) clearances on record.