PMA
N17578: INDIRECT FLUORESCENT-ANTIBODY TEST FOR GONORRHEA (IFA-GC)
FDA PMA · Aerojet Medical and Biological Systems
Key facts
| PMA number | N17578 |
|---|---|
| Trade name | INDIRECT FLUORESCENT-ANTIBODY TEST FOR GONORRHEA (IFA-GC) |
| Applicant | Aerojet Medical and Biological Systems |
| Approval date | May 28, 1976 |
At a glance
- None Supplements
- May 28, 1976 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- None 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: