Omics Core

Next Generation Sequencing Based Tumor Profiling Test

NantHealth, Inc.

The following data is part of a premarket notification filed by Nanthealth, Inc. with the FDA for Omics Core.

Pre-market Notification Details

Device IDK190661
501k NumberK190661
Device Name:Omics Core
ClassificationNext Generation Sequencing Based Tumor Profiling Test
Applicant NantHealth, Inc. 9920 Jefferson Blvd Culver City,  CA  90232
ContactAleece Nolasco
CorrespondentAleece Nolasco
NantHealth, Inc. 9920 Jefferson Blvd Culver City,  CA  90232
Product CodePZM  
CFR Regulation Number866.6080 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyPathology
501k Review PanelPathology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-14
Decision Date2019-11-09

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.