23andMe Submits Documents for 510(k) Clearance from FDA | GenomeWeb

NEW YORK (GenomeWeb News) – 23andMe today announced that it has started the process for regulatory clearance of its Personal Genome Service.

The Mountain View, Calif.-based consumer genetics testing firm said it has submitted its first round of 510(k) documentation to the US Food and Drug Administration, addressing concerns on the agency's part about tests such as those offered by 23andMe that are marketed directly to the public.

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