PMA supplement
P110031 S010: ELECSYS ANTI-HBC IGM ASSAY (COBAS E 411 ANALYZER)
FDA PMA supplement · Special (Immediate Track) · Roche Diagnostics Corp.
Key facts
| Original PMA | P110031 |
|---|---|
| Supplement number | S010 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | ELECSYS ANTI-HBC IGM ASSAY (COBAS E 411 ANALYZER) |
| Generic name | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
| Applicant | Roche Diagnostics Corp. |
| Product code | LOM |
| Received date | Jul 19, 2013 |
| Decision date | Aug 6, 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: