Someone recently referenced this line from the FDA ANN...
The FDA has completed its review of this new application and determined that FebriDx has demonstrated substantial equivalence to the predicate device cited in this application
That would suggest there is a similar device on the market. LDX actually referenced the other device in order to substantiate their FDA application. Next step would be trying to find out who it is they referenced.
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Someone recently referenced this line from the FDA ANN...The FDA...
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