FDA 510(k) Application Details - K190661

Device Classification Name	More FDA Info for this Device
510(K) Number	K190661
Device Name	Omics Core
Applicant	NantHealth, Inc. 9920 Jefferson Blvd Culver City, CA 90232 US Other 510(k) Applications for this Company
Contact	Aleece Nolasco Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/14/2019
Decision Date	11/09/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review