It is quite interesting how some people are misinterpreting the 510(k) clearance! FDA can't clear a device that is not as safe and effective as existing ones.
Here is information from FDA website:
"A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims."
Ann: Lumos Receives US FDA Clearance for FebriDx, page-405
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