PMA
N50407: STERILE TROBICIN SUSCEPTIBILITY POWDER(STERILE SPE
FDA PMA · Susceptibility test powders, antimicrobial · The Upjohn Co.
Key facts
| PMA number | N50407 |
|---|---|
| Trade name | STERILE TROBICIN SUSCEPTIBILITY POWDER(STERILE SPE |
| Generic name | Susceptibility test powders, antimicrobial |
| Applicant | The Upjohn Co. |
| Owner/operator | PFIZER INC. |
| Product code | JTT |
| Approval date | Jun 30, 1971 |
| Establishment registration | 1810189 |
| FEI number | 1810189 |
At a glance
- None Supplements
- Jun 30, 1971 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- None 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: