Foundation Medicine Inc

FDA Filings

This page includes the latest FDA filings for Foundation Medicine Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010679023
FEI Number3010679023
NameFOUNDATION MEDICINE, INC.
Owner & OperatorFoundation Medicine, Inc.
Contact Address150 Second St 1st Floor
Cambridge MA 02141 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address150 Second St 1st Floor
Cambridge, MA 02141 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Foundation Medicine, Inc.
FoundationOne CDx2020-05-19
Foundation Medicine, Inc.
FoundationOne CDx (F1CDx)2020-05-13
Foundation Medicine, Inc.
FoundationOne CDx (F1CDx)2020-04-17
Foundation Medicine, Inc.
FoundationOne CDx2019-11-06
Foundation Medicine, Inc.
FoundationOne CDx (F1CDx)2019-08-21
Foundation Medicine, Inc.
FoundationOne CDx (F1CDx)2019-07-01
Foundation Medicine, Inc.
FoundationOne CDx2019-07-01
Foundation Medicine, Inc.
FoundationOne CDx Assay2019-04-10
Foundation Medicine, Inc.
FoundationOne CDx2018-12-18
Foundation Medicine, Inc.
FoundationOne CDx (F1CDx)2018-10-11
FOUNDATION MEDICINE, INC
FoundationFocus CDx BRCA HRD2018-04-06
FOUNDATION MEDICINE, INC.
FoundationOne CDx2017-12-15
Foundation Medicine, Inc.
FoundationOne CDx2017-11-30
FOUNDATION MEDICINE, INC.
FoundationFocus CDxBRCA2017-01-03
FOUNDATION MEDICINE, INC
FoundationFocus CDxBRCA2016-12-19

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