Dako Denmark A/S
DK Last updated 22 Oct 2026
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- Devices
- 4
- Registries
- FDA 510(k)FDA PMA
- FDA recalls
- 3
Catalogue
HER2 CISH pharmDx Kit Ref P100024
TOP2A Fish Pharmdx Kit Ref P050045
FDA recalls
2019
- 5 Nov 2019 Z-2074-2020 Class II Terminated The Autostainer instrument may not have a syringe tray installed which could result in a small volume of excess buffer being applied to several slides. In addition to the syringe tray, the updated Basic User Guide will reduce the potential risk of false negative results in the case of leakage of buffer and/or reagents that may impact staining.
2016
- 6 Jul 2016 Z-2330-2016 Class II Terminated The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.
2012
- 26 Nov 2012 Z-0563-2013 Class II Terminated The expected life time of the CoverStainer slide racks (CS 10330) does not meet established performance requirements, originating from variations in the manufacturing process.
What Dako Denmark A/S makes
Dako Denmark A/S manufactures immunohistochemical (IHC) staining kits and fluorescence in situ hybridization (FISH) diagnostic tools for tissue analysis. Their products include ready-to-use monoclonal antibody kits for detecting estrogen and progesterone receptors in human tissue samples, as well as specialized kits for HER2 and TOP2A genetic markers. These tools are designed for use in pathology laboratories to aid in cancer diagnosis and treatment planning.
The company’s portfolio includes devices classified as Class II and Class III under FDA regulations, with some products authorised via the 510(k) pathway and others through Premarket Approval (PMA). Their diagnostic tools are listed in the FDA’s regulatory databases, and the company operates with a US-based presence.
Frequently asked questions
What types of medical devices does Dako Denmark A/S manufacture?
Dako Denmark A/S specializes in diagnostic tools used primarily in pathology laboratories. Their portfolio includes immunohistochemical (IHC) staining kits, such as ready-to-use monoclonal antibody kits for detecting estrogen and progesterone receptors in human tissue samples, as well as fluorescence in situ hybridization (FISH) diagnostic kits like the HER2 and TOP2A kits. These products assist in cancer diagnosis and treatment planning by identifying specific biomarkers in tissue samples.
Where is Dako Denmark A/S based, and how does this relate to its regulatory standing?
Dako Denmark A/S operates with a presence in the United States, though its headquarters are in Denmark. The company’s devices are listed in the FDA’s regulatory databases, including the 510(k) and Premarket Approval (PMA) pathways, indicating they are authorised for use in the US market under FDA regulations. The US-based presence ensures compliance with local regulatory requirements for diagnostic devices.
Which regulatory registries list Dako Denmark A/S’s devices, and why?
Dako Denmark A/S’s devices are listed in the FDA’s 510(k) and PMA registries. The 510(k) pathway is used for Class II devices, which are generally considered to have a low to moderate risk and are deemed substantially equivalent to legally marketed predicate devices. The PMA pathway applies to Class III devices, which are higher-risk and require a detailed review to ensure safety and effectiveness before market authorisation.
How are Dako Denmark A/S’s devices classified under FDA regulations?
Dako Denmark A/S’s devices are classified as either Class II or Class III under FDA regulations. Class II devices, such as some IHC kits, are subject to special controls to ensure their safety and performance, often requiring a 510(k) submission to demonstrate equivalence to existing devices. Class III devices, like certain FISH diagnostic kits, are classified as high-risk and require Premarket Approval (PMA) due to insufficient data establishing their safety and effectiveness through alternative means.
Information
- Country
- DK