PMA supplement
P050042 S037: ARCHITECT Anti-HCV (LN 1L79)
FDA PMA supplement · 30-Day Notice · Abbott Laboratories, Inc.
Key facts
| Original PMA | P050042 |
|---|---|
| Supplement number | S037 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | ARCHITECT Anti-HCV (LN 1L79) |
| Generic name | Assay, enzyme linked immunosorbent, hepatitis c virus |
| Applicant | Abbott Laboratories, Inc. |
| Product code | MZO |
| Received date | Oct 12, 2018 |
| Decision date | Nov 9, 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: