Somatic Gene Mutation Detection System — Roche Molecular System, Inc. (PMA P200014)
Somatic Gene Mutation Detection System — Roche Molecular System, Inc. (PMA P200014) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Somatic Gene Mutation Detection System; Applicant: Roche Molecular System, Inc.; Clearance track: PMA.
| Device name | Somatic Gene Mutation Detection System |
|---|---|
| Applicant | Roche Molecular System, Inc. |
| Clearance track | PMA |
| Submission number | P200014 |
| Decision | APPR |
| Decision date | 2020-06-18 |
| Date received | 2020-03-02 |
| Product code | OWD |
| Device class | 3 |
| Medical specialty | Unknown |
| Applicant location | CA |
| Source | openFDA device |
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$1999/mo
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