Guardant Health Inc 505 Penobscot Driveredwood City Ca 94063 Pma Numberp200010 Supplement Numbers005 Date Received12 17 2021 Decision Date03 16 2022 Product Code Pqp Advisory Committee Pathology Supplement Typereal Time Process Supplement Reason Change Design Components Specifications Material 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 Numbers005 Date Received12 17 2021 Decision Date03 16 2022 Product Code Pqp Advisory Committee Pathology Supplement Typereal Time Process Supplement Reason Change Design Components Specifications Material Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
Guardant Health, Inc.505 Penobscot Driveredwood City, CA 94063 PMA NumberP200010 Supplement NumberS005 Date Received12/17/2021 Decision Date03/16/2022 Product Code PQP  Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
 Guardant360 CDx2022-03-16

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