510(k) K160885

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

K160885 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 October 27, 2016. 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.