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Kag

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Posts 788
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Alias Born 02/01/2006

Kag

Re: bocxman post# 2212

Monday, 02/20/2006 3:23:33 PM

Monday, February 20, 2006 3:23:33 PM

Post# of 30387
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



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