510(k) K183102

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

K183102 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 Concentrated Liquid Mouse Monoclonal Antibody". The FDA issued a decision of Substantially Equivalent on Dec 7, 2018. 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 2 other 510(k) clearances on record.