NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)— 510(k) K202304
Substantially EquivalentNyu Langone Medical Center
FDA 510(k) clearance K202304 for NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets), Substantially Equivalent on 2021-07-14. Applicant: Nyu Langone Medical Center. Device class: 2.
Clearance details
- Applicant
- Nyu Langone Medical Center
- 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
- New York, NY, US
Recent devices under product code PZM
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