510(k) K170005

FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) by Dako Denmark A/S — Product Code MXZ

K170005 is an FDA 510(k) premarket notification submitted by Dako Denmark A/S for the device "FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)". The FDA issued a decision of Substantially Equivalent on December 21, 2017. The device falls under product code MXZ (Immunohistochemistry Assay, Antibody, Progesterone Receptor), a Class II device regulated under 21 CFR 864.1860. Dako Denmark A/S has at least 1 other 510(k) clearance on record.