PMA supplement
P090008 S021: Elecsys Anti-HCV Immunoassay
FDA PMA supplement · Normal 180 Day Track No User Fee · Roche Diagnostics Corp.
Key facts
| Original PMA | P090008 |
|---|---|
| Supplement number | S021 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Elecsys Anti-HCV Immunoassay |
| Generic name | Assay, enzyme linked immunosorbent, hepatitis c virus |
| Applicant | Roche Diagnostics Corp. |
| Product code | MZO |
| Received date | Oct 26, 2018 |
| Decision date | Apr 24, 2019 |
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: