PMA supplement
P870049 S032: MICROSCAN RAPID GRAM POSITIVE FLUOROGENIC PANELS
FDA PMA supplement · Normal 180 Day Track · Dade Intl., Inc.
Key facts
| Original PMA | P870049 |
|---|---|
| Supplement number | S032 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | MICROSCAN RAPID GRAM POSITIVE FLUOROGENIC PANELS |
| Generic name | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION |
| Applicant | Dade Intl., Inc. |
| Product code | LON |
| Received date | Nov 5, 2001 |
| Decision date | Nov 30, 2001 |
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: