|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
COBAS 4800 BRAF V600 MUTATION TEST
|
Roche Molecular Systems, Inc. |
P110020 S012 |
01/15/2015 |
COBAS 4800 BRAF V600 MUTATION TEST
|
Roche Molecular Systems, Inc. |
P110020 S013 |
04/09/2015 |
ROCHE COBAS DNA SAMPLE PREPARATION KIT, ROCHE COBA...
|
Roche Molecular Systems, Inc. |
P110020 S014 |
07/23/2015 |
COBAS KRAS MUTATION TEST
|
Roche Molecular Systems, Inc. |
P140023 |
05/07/2015 |
ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SA...
|
Roche Molecular Systems, Inc. |
P140023 S001 |
07/23/2015 |
ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SA...
|
Roche Molecular Systems, Inc. |
P140023 S002 |
09/24/2015 |
COBAS EGFR MUTATION TEST
|
ROCHE |
P120019 S005 |
01/15/2015 |
COBAS EGFR MUTATION TEST
|
ROCHE |
P120019 S006 |
04/09/2015 |
COBAS EGFR MUTATION TEST V2
|
ROCHE |
P120019 S007 |
11/13/2015 |
ROCHE COBAS EGFR MUTATION TEST, ROCHE COBAS DNA SA...
|
ROCHE |
P120019 S008 |
07/23/2015 |