PMA
P990045: DIASORIN ETI-AB-COREK PLUS ASSAY
FDA PMA · DiaSorin, Inc.
Key facts
| PMA number | P990045 |
|---|---|
| Trade name | DIASORIN ETI-AB-COREK PLUS ASSAY |
| Applicant | DiaSorin, Inc. |
| Owner/operator | DiaSorin Inc. |
| Approval date | Mar 30, 2001 |
| Docket number | 01M-0456 |
| Notice date | Oct 9, 2001 |
| Establishment registration | 2182595 |
| FEI number | 2182595 |
At a glance
- 10–99 Supplements
- Dec 21, 2021 Latest supplement decision
- No Withdrawn
- Yes 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: