GUARDANT HEALTH, INC (Campus)

Matched from indexed company URL: Guardant Health, Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3012090384	3012090384	GUARDANT HEALTH, INC (Campus)	1	N	2026-01-01	505 Penobscot Dr Redwood City CA US 94063

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
279687	1296490539	P250027	Guardant360® Liquid CDx	PQP	2026-05-19
279687	1564672466	P230009	Shield	PHP	2024-07-26
279687	1657043460	P200010	Guardant360 CDx	PQP	2020-08-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
PQP	1	2020-08-07

PMA#

Guardant360® CDx

2022-07-29

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 Chan...

Guardant360 CDx

2022-03-16

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 D...

Guardant360® CDx

2022-02-28

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 Chan...