|
Device | COBAS 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 | S010 |
Date Received | 12/13/2013 |
Decision Date | 03/12/2014 |
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 CHANGES TO THE COBAS® 4800 SR2 SYSTEM SOFTWARE ARCHITECTURE AND ASSAY SPECIFIC ANALYSIS PACKAGE (ASAP) SOFTWARE FOR THE COBAS® BRAF V600 MUTATION TEST AND COBAS® EGFR MUTATION TEST. |