Dako Denmark A/S
Dako Denmark A/S holds FDA 510(k) medical device clearances, cleared in 2017, with 3 FDA device recalls on record.
Top product codes for Dako Denmark A/S
FDA recalls by Dako Denmark A/S
- Z-2074-2020 — Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800.
- Z-2330-2016 — EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
- Z-0563-2013 — CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrument. The purpose is to hold microscopic slides, during transfer through the staining process. The rack can hold up to 10 slides at a time, and is necessary for optimal CoverStainer instrument performance.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Dako Denmark A/S
Data sourced from openFDA. This site is unofficial and independent of the FDA.