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Re: Random31 post# 633

Friday, 11/10/2017 11:54:50 AM

Friday, November 10, 2017 11:54:50 AM

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It was because they were marketing it as a primary detection device which I believe the FDA said the finding in the study they did meet that. They just recontacted the FDA and will perform another 9 month trial to give them the data that was told to them by the FDA they needed to meet their standards. That was in May.

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