PGDx elio tissue complete— 510(k) K192063
Substantially EquivalentPersonal Genome Diagnostics
FDA 510(k) clearance K192063 for PGDx elio tissue complete, Substantially Equivalent on 2020-04-24. Applicant: Personal Genome Diagnostics. Device class: 2.
Clearance details
- Applicant
- Personal Genome Diagnostics
- Product code
- Code PZM
- Device class
- Class 2
- Regulation
- 21 CFR 866.6080
- Advisory panel
- Pathology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Baltimore, MD, US
Recent devices under product code PZM
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