510(k) K103834

BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS by Bio-Rad Laboratories — Product Code MID

K103834 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories for the device "BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS". The FDA issued a decision of Substantially Equivalent on March 30, 2012. The device falls under product code MID (System, Test, Anticardiolipin Immunological), a Class II device regulated under 21 CFR 866.5660. Bio-Rad Laboratories has at least 10 other 510(k) clearances on record.