PMA
N50510: VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD
FDA PMA · Susceptibility test cards, antimicrobial · Biomerieux Vitek, Inc.
Key facts
| PMA number | N50510 |
|---|---|
| Trade name | VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD |
| Generic name | Susceptibility test cards, antimicrobial |
| Applicant | Biomerieux Vitek, Inc. |
| Owner/operator | BIOMERIEUX SA |
| Product code | LTW |
| Approval date | Mar 2, 1978 |
| Establishment registration | 1950204 |
| FEI number | 1950204 |
At a glance
- 100–999 Supplements
- Oct 17, 2001 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 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: