FOUNDATION MEDICINE, INC.

FDA Device Registration & Listing · Cambridge, MA, US · Registration 3010679023

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
3010679023
FEI Number
3010679023
Entity Name
FOUNDATION MEDICINE, INC.
City/State/Country
Cambridge, MA, US
Establishment Address
150 Second St, 1st Floor, Cambridge, MA 02141, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
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
P190032

All Registered Proprietary Names

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

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
3031598391 FOUNDATION MEDICINE, INC. Boston, MA, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010679023. Last updated year: 2026. Please use registration number 3010679023 when referencing this establishment in official correspondence.
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