PMA
P890014: HA-IGMK AND ETI-HA-IGMK
FDA PMA · Hepatitis a test (antibody and igm antibody) · DiaSorin, Inc.
Key facts
| PMA number | P890014 |
|---|---|
| Trade name | HA-IGMK AND ETI-HA-IGMK |
| Generic name | Hepatitis a test (antibody and igm antibody) |
| Applicant | DiaSorin, Inc. |
| Owner/operator | DiaSorin Inc. |
| Product code | LOL |
| Approval date | Jul 24, 1990 |
| Docket number | 90M-0251 |
| Notice date | Aug 10, 1990 |
| Establishment registration | 2182595 |
| FEI number | 2182595 |
At a glance
- 1–9 Supplements
- Dec 14, 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- No Withdrawn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: