|
Device | THERASCREEN EGFR RGQ PCR KIT |
Generic Name | Somatic gene mutation detection system |
Applicant | QIAGEN GmbH QIAGEN Strasse 1 Hilden 40724 |
PMA Number | P120022 |
Supplement Number | S014 |
Date Received | 12/28/2016 |
Decision Date | 05/19/2017 |
Product Code |
OWD |
Advisory Committee |
Pathology |
Clinical Trials | NCT00949650
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to the Instructions for Use. |