MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay
FDA 510(k) clearance DEN170058 · decided 2017-11-15
Clearance details
- K-number
- DEN170058
- Device name
- MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay
- Applicant
- Memorial Sloan-Kettering Cancer Center
- Decision
- Unknown
- Date received
- 2017-09-25
- Decision date
- 2017-11-15
- Days to decision
- 51 days
- Clearance type
- Direct
- Product code
- PZM
- Device class
- 2
- Regulation number
- 866.6080
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.