|
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 | S011 |
Date Received | 12/13/2013 |
Decision Date | 01/09/2014 |
Product Code |
OWD |
Advisory Committee |
Pathology |
Clinical Trials | NCT01107418
|
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement CHANGE TO DISCONTINUE CHEMICAL TESTING FOR POTASSIUM CONCENTRATION IN MASTERMIXES. |