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Friday, 30 November 2018

FDA Updates Draft Guidance for Dual CLIA Waiver, 501(k) Process - 360Dx

FDA Updates Draft Guidance for Dual CLIA Waiver, 501(k) Process  360Dx

The draft guidance has been reissued with updates based on industry comments and is intended to lay out the steps necessary to get simultaneous 510(k) and ...



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