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Somatic Gene Mutation Detection System — Roche Molecular Systems, Inc. (PMA P110020)

Somatic Gene Mutation Detection System — Roche Molecular Systems, Inc. (PMA P110020) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Somatic Gene Mutation Detection System; Applicant: Roche Molecular Systems, Inc.; Clearance track: PMA.

Device nameSomatic Gene Mutation Detection System
ApplicantRoche Molecular Systems, Inc.
Clearance trackPMA
Submission numberP110020
DecisionOK30
Decision date2018-07-26
Date received2018-06-29
Product codeOWD
Device class3
Medical specialtyUnknown
Applicant locationCA
SourceopenFDA device

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