Webb27 okt. 2015 · Heavily redacted inspection reports, posted Tuesday by the FDA, said Theranos’s “design validation did not ensure the device conforms to defined user needs … Webb17 okt. 2024 · The FDA concluded in 2015 that the nanocontainer was a Class II device, which requires special labels, certain performance standards and post-market …
‘Selling a promise’: what Silicon Valley learned from the fall of …
WebbThe test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for use in a pediatric population, neonates and … WebbTheranos, I n c. 7333 Gate wa y Bl vd . CIIY,8TATE.Zli'OO , rrRY Newark, CA 94560 . Medical Devi ce Manufacturer . This document ... FDA atthe phone number and address above. fly and help live show
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION - Food and …
WebbTheranos is a private health care and life sciences company with the stated mission to revolutionize medical laboratory testing through allegedly innovative methods for … Webbför 2 dagar sedan · As explained by www.theconversation.com, Theranos labeled their nanotainer device as laboratory-developed, which per its guidelines doesn't require pre … WebbTheranos, the blood-testing company founded by Elizabeth Holmes and valued at $9 billion dollars, received FDA clearance today for its herpes test, the company announced. fly and help rundflug