PMA supplement
N17985 S001: GONOSTICON DRI-DOT
FDA PMA supplement · Organon, Inc.
Key facts
| Original PMA | N17985 |
|---|---|
| Supplement number | S001 |
| Trade name | GONOSTICON DRI-DOT |
| Generic name | KIT, IDENTIFICATION, NEISSERIA GONORRHOEAE |
| Applicant | Organon, Inc. |
| Product code | JSX |
| Received date | Feb 23, 1981 |
| Decision date | Apr 14, 1981 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: