|
Device | ROCHE COBAS DNA SAMPLE PREPARATION KIT,059855536190 AND ROCHE COBAS 4800 BRAF V600 MUTATION KIT, 05985579190 |
Generic Name | Somatic gene mutation detection system |
Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588-2722 |
PMA Number | P110020 |
Supplement Number | S006 |
Date Received | 09/12/2012 |
Decision Date | 01/10/2013 |
Product Code |
OWD |
Advisory Committee |
Pathology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE ADDITION OF POLY RA TO THE BRAF MUTANT AND WILD-TYPE CONTROLS BUFFER MATRIX AND ASSOCIATED MANUFACTURING PROCESS CHANGES. |