PMA
P110020: COBAS 4800 BRAF V600 MUTATION TEST
FDA PMA · Somatic gene mutation detection system · Roche Molecular Systems, Inc.
Key facts
| PMA number | P110020 |
|---|---|
| Trade name | COBAS 4800 BRAF V600 MUTATION TEST |
| Generic name | Somatic gene mutation detection system |
| Applicant | Roche Molecular Systems, Inc. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | OWD |
| Approval date | Aug 17, 2011 |
| Docket number | 11M-0601 |
| Notice date | Aug 19, 2011 |
| Establishment registration | 2243471 |
| FEI number | 2243471 |
At a glance
- 10–99 Supplements
- Mar 17, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: