Vox writes in The Theranos controversy, explained:
After all, the evidence on this wasn't public: The Food and Drug Administration (FDA) hadn't cleared Theranos's tests.
On the other hand Theranos claims that the FDA did give it a clearance for it's herpes simplex virus test:
FDA has already cleared one of those tests, including our underlying test systems and Nanotainer™ tubes, for use in detecting the herpes simplex virus (HSV-1).
Is the Vox summary that says that the FDA didn't gave any clearance wrong?