GUARDANT HEALTH, INC (Campus)

FDA Device Registration & Listing · Redwood City, CA, US · Registration 3012090384

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012090384
FEI Number
3012090384
Entity Name
GUARDANT HEALTH, INC (Campus)
City/State/Country
Redwood City, CA, US
Establishment Address
505 Penobscot Dr, Redwood City, CA 94063, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Guardant Health, Inc (Owner Number: 10078033)
Owner / Operator Contact Address
505 Penobscot Dr, Redwood City, CA 94063, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P200010

All Registered Proprietary Names

Guardant360® Liquid CDx Guardant360 CDx

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown Class 3 N/A 2026-05-26
PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown Class 3 N/A 2020-10-08

Official Correspondent

Nameeta Mujumdar

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Guardant Health, Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012090384. Last updated year: 2026. Please use registration number 3012090384 when referencing this establishment in official correspondence.
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