|
Device | cobas 4800 BRAF V600 Mutation Test |
Generic Name | Somatic gene mutation detection system |
Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588-2722 |
PMA Number | P110020 |
Supplement Number | S033 |
Date Received | 06/27/2019 |
Decision Date | 09/25/2019 |
Product Code |
OWD |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a formulation change to the cobas® DNA Sample Preparation Kit used with the cobas® 4800 BRAF V600 Mutation Test (P110020). |