PMA supplement
P110020 S006: ROCHE COBAS DNA SAMPLE PREPARATION KIT,059855536190 AND ROCHE COBAS 4800 BRAF V600 MUTATION KIT, 05985579190
FDA PMA supplement · Normal 180 Day Track · Roche Molecular Systems, Inc.
Key facts
| Original PMA | P110020 |
|---|---|
| Supplement number | S006 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | 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. |
| Product code | OWD |
| Received date | Sep 12, 2012 |
| Decision date | Jan 10, 2013 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: