PMA supplement
BP900002 S004: IMx Core-M Assay
FDA PMA supplement · Special Supplement · Abbott Laboratories
Key facts
| Original PMA | BP900002 |
|---|---|
| Supplement number | S004 |
| Supplement type | Special Supplement |
| Trade name | IMx Core-M Assay |
| Generic name | Identification system for hepatitis b antigen |
| Applicant | Abbott Laboratories |
| Product code | KSJ |
| Received date | Oct 28, 2002 |
| Decision date | Dec 19, 2002 |
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: