510(k) K193393

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

K193393 is an FDA 510(k) premarket notification submitted by Leica Biosystems Newcastle, Ltd. for the device "BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).". The FDA issued a decision of Substantially Equivalent on March 6, 2020. 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, Ltd. has at least 2 other 510(k) clearances on record.