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Dako Denmark A/S

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2074-2020Class IIDako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, November 5, 2019
Z-2330-2016Class IIEnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistocJuly 6, 2016
Z-0563-2013Class IICoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrumenNovember 26, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K170028FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)December 21, 2017
K170005FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)December 21, 2017