Information for Health Care Professionals
As you may have already learned from other pages on this website, the U.S. FDA has cleared Onko-Sure® for post-diagnosis monitoring of colorectal patients. For your convenience, we have included a PDF version of the notice from the Office of In Vitro Diagnostic Device Evaluation and Safety, Center for devices and Radiological Health, pertaining to Onko-Sure.
Click below to download and read the PDF. It contains a copy of the notification letter and our accompanying 510(k) summary documents for AMDL-ELISA DR-70.
FDA Clearance PDF–Click to Download
Questions? We’ love to hear from you. Please contact us at info@onko-sure.com.