|
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 | S013 |
Date Received | 03/13/2015 |
Decision Date | 04/09/2015 |
Product Code |
OWD |
Advisory Committee |
Pathology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO THE CURRENT SUPPLIER, AND A CHANGE TO THE MANUFACTURING PROCESS FORA REAGENT MATERIAL USED FOR THE COBAS® SYSTEMS. |