PMA supplement
P800029 S005: OMNISCEPT(TM) KB SYSTEM
FDA PMA supplement · Analytical Products, Inc.
Key facts
| Original PMA | P800029 |
|---|---|
| Supplement number | S005 |
| Trade name | OMNISCEPT(TM) KB SYSTEM |
| Generic name | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION |
| Applicant | Analytical Products, Inc. |
| Product code | LON |
| Received date | Dec 3, 1982 |
| Decision date | Jul 5, 1983 |
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: