510(k) K081286

MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 by Dako North America, Inc. — Product Code MYA

K081286 is an FDA 510(k) premarket notification submitted by Dako North America, Inc. for the device "MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634". The FDA issued a decision of Substantially Equivalent on May 8, 2009. The device falls under product code MYA (Immunohistochemistry Antibody Assay, Estrogen Receptor), a Class II device regulated under 21 CFR 864.1860. Dako North America, Inc. has at least 3 other 510(k) clearances on record.