Onko-Sure has been cleared by the FDA for marketing within the United States. To view the notice from the Office of In Vitro Diagnostic Device Evaluation and Safety, Center for devices and Radiological Health, click on the icon below to read or download a PDF copy of the notification letter and our accompanying 510(k) summary documents for AMDL-ELISA DR-70®.
FDA Clearance PDF–Click to Download
For additional information, please contact us at info@onko-sure.com.