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Dako North America, Inc.

FDA 510(k) & PMA Approved Devices — 3 products

Total Devices3
Categories3
Latest Approval2017-05-16
TypeNumberDevice NameCodeDate
PMA P040011 Immunohistochemistry antibody assay, c-kit NKF 2017-05-16 View
PMA P150027 Immunohistochemistry assay, antibody, programmed death-ligand 1 PLS 2016-12-01 View
510(k) K160922 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) MXZ 2016-05-03 View