510(k) K020023

DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING by Dako Corp. — Product Code MXZ

K020023 is an FDA 510(k) premarket notification submitted by Dako Corp. for the device "DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING". The FDA issued a decision of Substantially Equivalent on February 28, 2002. The device falls under product code MXZ (Immunohistochemistry Assay, Antibody, Progesterone Receptor), a Class II device regulated under 21 CFR 864.1860. Dako Corp. has at least 10 other 510(k) clearances on record.