PMA supplement
P030056 S013: Atellica IM Analyzer Hepatitis C (aHCV)
FDA PMA supplement · Real-Time Process · Siemens Healthcare Diagnostics
Key facts
| Original PMA | P030056 |
|---|---|
| Supplement number | S013 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Atellica IM Analyzer Hepatitis C (aHCV) |
| Generic name | Assay, enzyme linked immunosorbent, hepatitis c virus |
| Applicant | Siemens Healthcare Diagnostics |
| Product code | MZO |
| Received date | Jul 19, 2018 |
| Decision date | Sep 11, 2018 |
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: