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Unpacking Averages: How Accurate Do Class II Medical Devices Need to Be to Obtain 510(k) Clearance?

Health Law Advisor

Out of that list of snippets, I pulled out all of those snippets that had one of the keywords that I cared about in it. Such products might be useful in identifying people negative to the disease or condition at issue, even though the performance is not very good at identifying reliably those who are positive.

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