FOUNDATION MEDICINE, INC.

FDA Device Registration & Listing · Boston, MA, US · Registration 3031598391

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
3031598391
FEI Number
3031598391
Entity Name
FOUNDATION MEDICINE, INC.
City/State/Country
Boston, MA, US
Establishment Address
400 Summer St, Boston, MA 02210, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Foundation Medicine, Inc. (Owner Number: 10053707)
Owner / Operator Contact Address
400 Summer St, Boston, MA 02210, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P170019

All Registered Proprietary Names

FoundationOne® Liquid CDx FoundationOne® Liquid CDx FoundationOne 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 2020-09-17
PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown Class 3 N/A 2020-12-07
PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown Class 3 N/A 2017-12-15

Official Correspondent

Sean Bundy

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010679023 FOUNDATION MEDICINE, INC. Cambridge, MA, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031598391. Last updated year: 2026. Please use registration number 3031598391 when referencing this establishment in official correspondence.
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