510(k) K113211

HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL by Instrumentation Laboratory CO — Product Code GGN

K113211 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL". The FDA issued a decision of Substantially Equivalent on January 4, 2012. The device falls under product code GGN (Plasma, Coagulation Control), a Class II device regulated under 21 CFR 864.5425. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.