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 ID: K190661
• 510k Number: K190661
• Device Name: Omics Core
• Classification: Next Generation Sequencing Based Tumor Profiling Test
• Applicant: NantHealth, Inc. 9920 Jefferson Blvd Culver City, CA 90232
• Contact: Aleece Nolasco
• Correspondent: Aleece Nolasco; NantHealth, Inc. 9920 Jefferson Blvd Culver City, CA 90232
• Product Code: PZM
• CFR Regulation Number: 866.6080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-03-14
• Decision Date: 2019-11-09