510(k) K172903

HemosIL D-Dimer HS 500 by Instrumentation Laboratory CO — Product Code DAP

K172903 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HemosIL D-Dimer HS 500". The FDA issued a decision of Substantially Equivalent on November 22, 2017. 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.