510(k) K032868

REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 by Corgenix, Inc. — Product Code MID

K032868 is an FDA 510(k) premarket notification submitted by Corgenix, Inc. for the device "REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139". The FDA issued a decision of Substantially Equivalent on October 14, 2003. The device falls under product code MID (System, Test, Anticardiolipin Immunological), a Class II device regulated under 21 CFR 866.5660. Corgenix, Inc. has at least 10 other 510(k) clearances on record.