Data / Medical devices / United States / Foundation Medicine, Inc.
Foundation Medicine, Inc.: FDA-registered device maker in Boston, MA, United States, 4 PMA approvals
Foundation Medicine, Inc. is registered with the FDA (registration 3031598391) in Boston, MA, United States. It lists 1 device type. The FDA files 4 PMA approvals under its listings, the newest dated November 6, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031598391
- Address
- 400 Summer St, Boston, MA, United States, 02210
- Owner or operator
- Foundation Medicine, Inc. (10053707)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 15, 2017
- Registered through
- 2026
- Brand names listed
- FoundationOne CDx, FoundationOne® Liquid CDx
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, Specification developer | 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 |
|---|---|---|---|---|---|---|
| November 6, 2020 | P200016 | FoundationOne Liquid CDx | PQP | 2 | March 8, 2023 | accessdata.fda.gov |
| October 26, 2020 | P200006 | FoundationOne Liquid CDx (F1 Liquid CDx) | PQP | 4 | March 8, 2023 | accessdata.fda.gov |
| August 26, 2020 | P190032 | FoundationOne Liquid CDx (F1 Liquid CDx) | PQP | 27 | September 18, 2026 | accessdata.fda.gov |
| November 30, 2017 | P170019 | FoundationOne CDx | PQP | 61 | September 16, 2026 | accessdata.fda.gov |
Compare with other makers
Updated March 8, 2023. 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.