Guardant Health Inc 505 Penobscot Driveredwood City Ca 94063 Pma Numberp200010 Supplement Numbers011 Date Received07 01 2022 Decision Date07 29 2022 Product Code Pqp Advisory Committee Pathology Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Guardant Health Inc 505 Penobscot Driveredwood City Ca 94063 Pma Numberp200010 Supplement Numbers011 Date Received07 01 2022 Decision Date07 29 2022 Product Code Pqp Advisory Committee Pathology Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMA P200010S011 Guardant Health, Inc.505 Penobscot Driveredwood City, CA 94063 PMA NumberP200010 Supplement NumberS011 Date Received07/01/2022 Decision Date07/29/2022 Product Code PQP  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Guardant360® CDx	2022-07-29