510(k) K092181

HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS by Instrumentation Laboratory CO — Product Code MID

K092181 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS". The FDA issued a decision of Substantially Equivalent on March 11, 2010. The device falls under product code MID (System, Test, Anticardiolipin Immunological), a Class II device regulated under 21 CFR 866.5660. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.