|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
FoundationOne CDx
|
Foundation Medicine, Inc. |
P170019 |
11/30/2017 |
FoundationOne CDx
|
Foundation Medicine, Inc. |
P170019 S002 |
12/18/2018 |
FoundationOne CDx (F1CDx)
|
Foundation Medicine, Inc. |
P170019 S003 |
10/11/2018 |
FoundationOne CDx
|
Foundation Medicine, Inc. |
P170019 S004 |
07/01/2019 |
FoundationOne CDx Assay
|
Foundation Medicine, Inc. |
P170019 S005 |
04/10/2019 |
FoundationOne CDx
|
Foundation Medicine, Inc. |
P170019 S006 |
12/03/2019 |
FoundationOne CDx
|
Foundation Medicine, Inc. |
P170019 S007 |
10/11/2019 |
FoundationOne CDx (F1CDx)
|
Foundation Medicine, Inc. |
P170019 S008 |
07/01/2019 |
FoundationOne CDx (F1CDx)
|
Foundation Medicine, Inc. |
P170019 S009 |
08/21/2019 |
FoundationOne CDx (F1CDx)
|
Foundation Medicine, Inc. |
P170019 S010 |
12/16/2019 |