FDA 510(k) Applications Submitted by DAKO NORTH AMERICA, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K130861 03/28/2013 MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) DAKO NORTH AMERICA, INC.
K160922 04/04/2016 FLEX 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) Dako North America, Inc.
K081286 05/07/2008 MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 DAKO NORTH AMERICA, INC.
K120663 03/05/2012 MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI DAKO NORTH AMERICA, INC.


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