PMA
N50531: SENSITITRE
FDA PMA · SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION · Trek Diagnostic Systems, Inc.
Key facts
| PMA number | N50531 |
|---|---|
| Trade name | SENSITITRE |
| Generic name | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION |
| Applicant | Trek Diagnostic Systems, Inc. |
| Owner/operator | Thermo Fisher Scientific |
| Product code | LON |
| Approval date | May 4, 1979 |
| Establishment registration | 8021914 |
| FEI number | 3002806332 |
At a glance
- 1–9 Supplements
- Mar 7, 1984 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- No Withdrawn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: