PMA
P780012: HAVAB
FDA PMA · Hepatitis a test (antibody and igm antibody) · Abbott Laboratories
Key facts
| PMA number | P780012 |
|---|---|
| Trade name | HAVAB |
| Generic name | Hepatitis a test (antibody and igm antibody) |
| Applicant | Abbott Laboratories |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | LOL |
| Approval date | Jan 19, 1979 |
| Docket number | 79M-0145 |
| Notice date | May 15, 1979 |
| Establishment registration | 1415939 |
| FEI number | 1415939 |
At a glance
- 10–99 Supplements
- Jul 30, 2004 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: