Bocxman,
Do you happen to have any written company sources, that you can refer me to, that states only a 510k will be required for FDA approval on a serum RECAF cancer detection test? In your post #2212 you said "The company has said time and again that only a 510k will be required as opposed to a PMA, and this implies that general screening is the preferred route." I agree with you that any serum RECAF cancer detection test will only indicate that cancer is present somewhere, and does not give the location. Thanks, kag