PMA supplement
P110029 S026: ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS
FDA PMA supplement · Real-Time Process · Abbott Laboratories
Key facts
| Original PMA | P110029 |
|---|---|
| Supplement number | S026 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS |
| Generic name | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
| Applicant | Abbott Laboratories |
| Product code | LOM |
| Received date | Jun 30, 2017 |
| Decision date | Sep 27, 2017 |
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: