K-numberK160922
Device nameFLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)
ApplicantDako North America, Inc.
Product codeMXZ
Device classClass II
Decision dateMay 3, 2016
DecisionSubstantially Equivalent
Regulation864.1860
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