510(k) K171753

BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 by Leica Biosystems Newcastle, Limited — Product Code MXZ

K171753 is an FDA 510(k) premarket notification submitted by Leica Biosystems Newcastle, Limited for the device "BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16". The FDA issued a decision of Substantially Equivalent on July 21, 2017. The device falls under product code MXZ (Immunohistochemistry Assay, Antibody, Progesterone Receptor), a Class II device regulated under 21 CFR 864.1860. Leica Biosystems Newcastle, Limited has at least 2 other 510(k) clearances on record.