|
Device | Roche cobas EFGR Mutation Test, v2.0 |
Generic Name | Somatic gene mutation detection system |
Applicant | ROCHE 4300 HACIENDA DRIVE PO BOX 9002 PLEASANTON, CA 94588 |
PMA Number | P120019 |
Supplement Number | S038 |
Date Received | 12/07/2023 |
Decision Date | 12/21/2023 |
Product Code |
OWD |
Advisory Committee |
Pathology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for described labeling changes in an update to the hazard information on the product labeling for cobas® KRAS Mutation Test and the cobas® DNASample Preparation Kit. |