510(k) K160922

FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link) by Dako North America, Inc. — Product Code MXZ

K160922 is an FDA 510(k) premarket notification submitted by Dako North America, Inc. for the device "FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)". The FDA issued a decision of Substantially Equivalent on May 3, 2016. The device falls under product code MXZ (Immunohistochemistry Assay, Antibody, Progesterone 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.