PMA supplement
P830028 S001: UNISCEPT(TM)
FDA PMA supplement · Analytical Products, Inc.
Key facts
| Original PMA | P830028 |
|---|---|
| Supplement number | S001 |
| Trade name | UNISCEPT(TM) |
| Generic name | Manual antimicrobial susceptibility test systems |
| Applicant | Analytical Products, Inc. |
| Product code | JWY |
| Received date | Jan 25, 1984 |
| Decision date | Mar 9, 1984 |
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: