FDA.reportPublic FDA data

FOUNDATION MEDICINE, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30106790233010679023FOUNDATION MEDICINE, INC.1N2026-01-01150 Second St 1st Floor Cambridge MA US 02141
30315983913031598391FOUNDATION MEDICINE, INC.1N2026-01-01400 Summer St Boston MA US 02210

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2032681914348279P200016FoundationOne Liquid CDxPQP2020-11-06
3485631914348279P200016FoundationOne Liquid CDxPQP2020-11-06
2032681307274528P200006FoundationOne Liquid CDx (F1 Liquid CDx)PQP2020-10-26
3485631307274528P200006FoundationOne Liquid CDx (F1 Liquid CDx)PQP2020-10-26
2032681915892398P190032FoundationOne Liquid CDx (F1 Liquid CDx)PQP2020-08-26
3485631915892398P190032FoundationOne Liquid CDx (F1 Liquid CDx)PQP2020-08-26
2032681298579158P170019FoundationOne CDxPQP2017-11-30
3485631298579158P170019FoundationOne CDxPQP2017-11-30
2032681079977302P160018FoundationFocus CDxBRCAPQP2016-12-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PQP 62020-11-06
PQP32017-11-30

PMA#