|
Device | ROCHE 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 | S001 |
Date Received | 09/19/2011 |
Decision Date | 10/17/2011 |
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 | Yes |
Approval Order Statement ADDITIONAL OF FUNCTIONAL TESTING AT THE FINAL VIAL STAGE IN THE MANUFACTURE OF THE DEVICE MUTATION POSITIVE CONTROL (MU) AND THE WILD-TYPE CONTROL (WT). |