PMA
P920031: EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
FDA PMA · CYCLOSPORINE · Dade Behring, Inc.
Key facts
| PMA number | P920031 |
|---|---|
| Trade name | EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY |
| Generic name | CYCLOSPORINE |
| Applicant | Dade Behring, Inc. |
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Product code | MKW |
| Approval date | Oct 2, 1996 |
| Docket number | 97M-0082 |
| Notice date | Mar 21, 1997 |
| Establishment registration | 2517506 |
| FEI number | 2517506 |
At a glance
- 1–9 Supplements
- Jul 24, 2002 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- No Withdrawn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: