Monday, October 03, 2011 9:01:38 PM
THE DEVICE ALTERS THE DIAGNOSTIC EFFECT, IMPACTING SAFETY AND EFFECTIVENESS..... KEEP READING, IT SIGNED BY MICHEAL D O HARA PHD:
https://viewer.zoho.com/docs/yHla9
This is back in 2009 when Dean was telling us that approval is imminent and the FDA letter was simply a labeling issue.Enough said...
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