The predicate appears to be the Synovasure Alpha Defensin Lateral Flow Test Kit lodged by CD Diagnostics which was bought by and is now sold under Zimmer Biomet.
FDA 501k
Synovasure Alpha Defensin Lateral Flow Test Kit
Still waiting to view the summary outcome for the FebriDx application I believe should be available soon once the site has been updated.
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- Ann: Lumos Receives US FDA Clearance for FebriDx
Ann: Lumos Receives US FDA Clearance for FebriDx, page-407
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