PMA supplement
P090007 S004: ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411
FDA PMA supplement · 135 Review Track For 30-Day Notice · Roche Diagnostics Corp.
Key facts
| Original PMA | P090007 |
|---|---|
| Supplement number | S004 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411 |
| Generic name | Assay, enzyme linked immunosorbent, hepatitis c virus |
| Applicant | Roche Diagnostics Corp. |
| Product code | MZO |
| Received date | Aug 17, 2011 |
| Decision date | Nov 16, 2011 |
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: