Brief: Lumos Diagnostics Says Advised By FDA That Febridx Did Not Demonstrate Substantial Equivalence To Predicate Device
11/07/2022 02:14
July 11 (Reuters) - Lumos Diagnostics Holdings Ltd LDX.AX :
* LUMOS DIAGNOSTICS - ADVISED BY U.S. FDA THAT FEBRIDX DID
NOT
DEMONSTRATE SUBSTANTIAL EQUIVALENCE TO PREDICATE DEVICE
* LUMOS DIAGNOSTICS HOLDINGS - CURRENTLY REVIEWING FEEDBACK
PROVIDED BY FDA IN ORDER TO DETERMINE NEXT STEPS
* LUMOS DIAGNOSTICS HOLDINGS LTD - FEBRIDX HAS NOT BEEN
GRANTED
CLEARANCE FOR MARKETING IN U.S.
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((Reuters.Briefs@thomsonreuters.com;))
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