Data / Medical devices / United States / GUARDANT HEALTH, INC (Campus)
GUARDANT HEALTH, INC (Campus): FDA-registered device maker in Redwood City, CA, United States, 3 PMA approvals
GUARDANT HEALTH, INC (Campus) is registered with the FDA (registration 3012090384) in Redwood City, CA, United States. It lists 2 device types. The FDA files 3 PMA approvals under its listings, the newest dated May 19, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3012090384
- Address
- 505 Penobscot Dr, Redwood City, CA, United States, 94063
- Owner or operator
- Guardant Health, Inc (10078033)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 8, 2020
- Registered through
- 2027
- Brand names listed
- Guardant360 CDx, Guardant360® Liquid CDx, Shield
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | PQP | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection | PHP | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 19, 2026 | P250027 | Guardant360® Liquid CDx | PQP | 1 | July 6, 2026 | accessdata.fda.gov |
| July 26, 2024 | P230009 | Shield | PHP | 17 | October 5, 2026 | accessdata.fda.gov |
| August 7, 2020 | P200010 | Guardant360 CDx | PQP | 30 | September 18, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- All makers of System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
Updated July 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.