PMA
P890019: AB -HAVK
FDA PMA · Hepatitis a test (antibody and igm antibody) · Diasorin
Key facts
| PMA number | P890019 |
|---|---|
| Trade name | AB -HAVK |
| Generic name | Hepatitis a test (antibody and igm antibody) |
| Applicant | Diasorin |
| Owner/operator | DiaSorin Inc. |
| Product code | LOL |
| Approval date | Jul 13, 1990 |
| Docket number | 90m-0245 |
| Notice date | Oct 1, 1990 |
| Establishment registration | 2182595 |
| FEI number | 2182595 |
At a glance
- 1–9 Supplements
- Dec 12, 2005 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- No Withdrawn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: