NYU Langone Genome PACT (Genome Profiling Of Actionable Cancer Targets)

Next Generation Sequencing Based Tumor Profiling Test

NYU Langone Medical Center

The following data is part of a premarket notification filed by Nyu Langone Medical Center with the FDA for Nyu Langone Genome Pact (genome Profiling Of Actionable Cancer Targets).

Pre-market Notification Details

Device IDK202304
510k NumberK202304
Device Name:NYU Langone Genome PACT (Genome Profiling Of Actionable Cancer Targets)
ClassificationNext Generation Sequencing Based Tumor Profiling Test
Applicant NYU Langone Medical Center 240 E 38th Street New York,  NY  10016
ContactMatija Snuderl
CorrespondentDerek Symula
New York State Department Of Health Wadsworth Center, Empire State Plaza P.O. Box 509 Albany,  NY  12237
Product CodePZM  
CFR Regulation Number866.6080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-08-14
Decision Date2021-07-14

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