510(k) K050544

HEMOSIL D-DIMER HS by Instrumentation Laboratory CO — Product Code DAP

K050544 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL D-DIMER HS". The FDA issued a decision of Substantially Equivalent on April 26, 2005. 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 CO has at least 10 other 510(k) clearances on record.