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Replies to post #23267 on DNAprint Genomics (DNAG)

Replies to #23267 on DNAprint Genomics (DNAG)
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DorseyE

04/01/05 10:21 AM

#23270 RE: frogdreaming #23267

frogdreaming, I know things are not moving as fast as I thought or hoped..... at least they are still moving.
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DorseyE

04/01/05 10:30 AM

#23271 RE: frogdreaming #23267

What's your opinion on this statement?...
FDA rules regarding pharmacogenomics testing are evolving, and management believes that a 510K filing may not be required in order to perform the service. We are seeking additional guidance from the FDA on this issue.