510(k) K110215

CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY by Ventana Medical Systems, Inc. — Product Code MYA

K110215 is an FDA 510(k) premarket notification submitted by Ventana Medical Systems, Inc. for the device "CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY". The FDA issued a decision of Substantially Equivalent on December 17, 2012. The device falls under product code MYA (Immunohistochemistry Antibody Assay, Estrogen Receptor), a Class II device regulated under 21 CFR 864.1860. Ventana Medical Systems, Inc. has at least 10 other 510(k) clearances on record.