Guardant Health Inc

FDA Filings

This page includes the latest FDA filings for Guardant Health Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USA

NASDAQ

DUNS 062527949

FDA Registration(s)

FDA Filings

Device Company	Device	Date
PMA P200010S002 Guardant Health, Inc.	Guardant360 CDx	2021-05-28
PMA P200010S001 Guardant Health, Inc.	Guardant360 CDx	2021-05-21
PMA P200010 Guardant Health, Inc.	Guardant360 CDx	2020-08-07

Similar & Related FDA Registered Companies

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
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
Guardant Health, Inc.505 Penobscot Driveredwood City, CA 94063 PMA NumberP200010 Supplement NumberS007 Date Received02/02/2022 Decision Date02/28/2022 Product Code PQP Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	6TVQ0	GUARDANT HEALTH, INC.
CAGE Code	6TVQ0	GUARDANT HEALTH, INC.
S.A.M. Registration	6TVQ0 [62527949]	GUARDANT HEALTH, INC.
SEC	0001576280	Guardant Health, Inc. of DELAWARE