510(k) K091556

HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS by Instrumentation Laboratory CO — Product Code MSV

K091556 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS". The FDA issued a decision of Substantially Equivalent on May 21, 2010. The device falls under product code MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)), a Class II device regulated under 21 CFR 866.5660. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.