Dako North America, Inc. - FDA 510(k) Cleared Devices
Recent clearances: FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link), MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK), MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dako North America, Inc. Pathology ✕
4 devices
Cleared
May 03, 2016
FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1,...
Pathology
29d
Cleared
Dec 09, 2013
MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636,...
Pathology
256d
Cleared
Feb 12, 2013
MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
Pathology
344d
Cleared
May 08, 2009
MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1,...
Pathology
366d