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A Note from the ARB:

The ARB is seeing a number of reports uploaded to ASHI accreditation applications that do not have the FDA disclaimer on patient reports. This is a recurring issue of labs failing to add this on their reports whether it is an electronic format or not. It is our belief that lab directors and/or lab managers may be looking at the Cleared 510K Submission list for premarket approval and believing the kit is FDA approved, therefore assuming the disclaimer is not needed. This site identifies those submissions from vendors that have cleared the 510K premarket submission process and approval for vendors to market their products to the public, not a list of the 510K Cleared or FDA Approved list of kits or devices. Labs must review the package insert for the FDA statement that the "assay is approved by the FDA." Here is the link to review the documentation submitted and the FDA supporting documentation. more

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