510(k) K133582

HEMOSIL D-DIMER HS 500 CONTROL by Instrumentation Laboratory — Product Code GGN

K133582 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory for the device "HEMOSIL D-DIMER HS 500 CONTROL". The FDA issued a decision of Substantially Equivalent on August 15, 2014. The device falls under product code GGN (Plasma, Coagulation Control), a Class II device regulated under 21 CFR 864.5425. Instrumentation Laboratory has at least 10 other 510(k) clearances on record.