510(k) K062467

AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10 by Axis-Shield Diagnostics, Ltd. — Product Code CDD

K062467 is an FDA 510(k) premarket notification submitted by Axis-Shield Diagnostics, Ltd. for the device "AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10". The FDA issued a decision of Substantially Equivalent on November 22, 2006. The device falls under product code CDD (Radioassay, Vitamin B12), a Class II device regulated under 21 CFR 862.1810. Axis-Shield Diagnostics, Ltd. has at least 10 other 510(k) clearances on record.