510(k) K130861

MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) by Dako North America, Inc. — Product Code MXZ

K130861 is an FDA 510(k) premarket notification submitted by Dako North America, Inc. for the device "MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)". The FDA issued a decision of Substantially Equivalent on December 9, 2013. 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.