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lakeshore555

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lakeshore555

Re: jimtash post# 18934

Monday, 12/02/2013 9:57:37 AM

Monday, December 02, 2013 9:57:37 AM

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23andMe was shut down because they failed to get FDA clearance for their medical device.

Simply having a device registered does not allow you to market that device. You need FDA clearance.

23andMe did not submit applications to the FDA until the FDA told them they needed to in 2009.

23andMe needs to submit a 510(kor PMA and get it cleared. Gartner will need to do the same.
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