PMA supplement
P790019 S002: HAVAB-M DIAGNOSTIC KIT
FDA PMA supplement · Abbott Laboratories
Key facts
| Original PMA | P790019 |
|---|---|
| Supplement number | S002 |
| Trade name | HAVAB-M DIAGNOSTIC KIT |
| Generic name | Hepatitis a test (antibody and igm antibody) |
| Applicant | Abbott Laboratories |
| Product code | LOL |
| Received date | Mar 4, 1982 |
| Decision date | Jun 25, 1982 |
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: