510(k) DEN170058
- Device
- MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay
- Applicant
- Memorial Sloan-Kettering Cancer Center
- 510(k) number
- DEN170058
- Product code
- PZM
- Decision
- Unknown (DENG)
- Decision date
- 2017-11-15
- Date received
- 2017-09-25
- Regulation
- 866.6080
- Classification name
- Next Generation Sequencing Based Tumor Profiling Test
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Christine England
- Address
- Dept. Of Pathology 444 E 68th St. H505 New York NY US 10065 10065
FDA Registration Numbers#
- 3003335080
- 3043140667
- 3013200421
- 3043050156
- 3011805506
Source Documents#
510(k) summary PDF not indicated by FDA
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