Opportunity, I will not debate on the possibility of a 501(k) or a PMA but you can do some more research on your own. Find a predicate to base the 501(k) upon. Then consider the time wasted going through the predicate process and then most likely getting a denial.
Be aware that some of the statements made by Wittenberg are out to lunch and the items in the filings about approval are there to make the investment seem as attractive as possible.
Look up the original PSA approval. You will then find that other PSA type tests were approved using the original as a predicate. Then research to see if you can find a predicate for RECAF. It is innovative and nothing out there is like it or I would not be in this investment.
Do you believe the Recaf serum test by Abbott will likely need Pre Market Approval from the FDA?
(Dr. Moro)I don't know. I'll tell you why I don't know. I was talking to these other big guys and I talked to a big company on Tuesday, they came over here. They sell about 16 million PSA tests a year. Some of them think they can get away with a 510K and some think they will need Pre Market Approval.
Relax guys.....(IMHO)We are finally getting to the good part of this event. the fighting between us should have been over long ago.
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