PMA supplement
P110029 S042: ARCHITECT HBsAg Qualitative / HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative II / HBsAg Qualitative II Conf
FDA PMA supplement · Normal 180 Day Track · Abbott Laboratories
Key facts
| Original PMA | P110029 |
|---|---|
| Supplement number | S042 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | ARCHITECT HBsAg Qualitative / HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative II / HBsAg Qualitative II Conf |
| Applicant | Abbott Laboratories |
| Received date | May 8, 2023 |
| Decision date | Oct 11, 2023 |
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: