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Dako Denmark A/S

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

Total Devices3
Categories3
Latest Approval2017-12-21
TypeNumberDevice NameCodeDate
510(k) K170028 FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) MYA 2017-12-21 View
510(k) K170005 FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) MXZ 2017-12-21 View
PMA P100024 Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer NYQ 2016-09-27 View