Bioelectronics Corp (BIEL)

[GetSeriousOK]

You are correct. The FDA doesn't use the word "reject."

I, however, do use that word when it applies, as it does in this case: the FDA rejected BIEL's 510(k) by telling BIEL they will not clear a 510(k) for the ActiPatch.

Not the current 510(k) and not any other 510(k) because an applicable predicate device does not exist. Read my past posts -- I've been saying that for eight months. Now the FDA said it.