510(k) K110579

ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS by Abbott Laboratories — Product Code CDD

K110579 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS". The FDA issued a decision of Substantially Equivalent on Oct 6, 2011. The device falls under product code CDD (Radioassay, Vitamin B12), a Class II device regulated under 21 CFR 862.1810. Abbott Laboratories has at least 10 other 510(k) clearances on record.