510(k) K082859

HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED by Instrumentation Laboratory CO — Product Code GGN

K082859 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED". The FDA issued a decision of Substantially Equivalent on December 19, 2008. 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.