Working with the FDA from Day One
Athelas has collected large amounts of clinical data about our device, all submitted to the FDA currently under review.
FDA Class 2
Submitted
Athelas has conducted clinical studies meant to show equivalence to predicate devices for the WBC and Neut% parameters - these are currently under evaluation by the FDA.
Externally Validated
Precision and Accuracy
We take accuracy and transparency seriously. Read our third-party clinical white paper on the accuracy of our capillary WBC and Neutrophil results versus venous blood samples on the Sysmex XE-5000.
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