it was approved for a single test.
<a href="http:&#x2F;&#x2F;fortune.com&#x2F;2015&#x2F;07&#x2F;02&#x2F;theranos-fda-approval&#x2F;" rel="nofollow">http:&#x2F;&#x2F;fortune.com&#x2F;2015&#x2F;07&#x2F;02&#x2F;theranos-fda-approval&#x2F;</a>
dunno if they ever got the device in a functional state, <i>outside of extremely controlled conditions in a lab</i>.