PMA
N50036: STREPTOMYCIN SUEFATE DIAGNOSTIC SUSCEPTIBILITY POW
FDA PMA · Susceptibility test powders, antimicrobial · Pfizer, Inc.
Key facts
| PMA number | N50036 |
|---|---|
| Trade name | STREPTOMYCIN SUEFATE DIAGNOSTIC SUSCEPTIBILITY POW |
| Generic name | Susceptibility test powders, antimicrobial |
| Applicant | Pfizer, Inc. |
| Owner/operator | PFIZER INC. |
| Product code | JTT |
| Approval date | Nov 24, 1969 |
| Establishment registration | 3009712172 |
| FEI number | 3009712172 |
At a glance
- None Supplements
- Nov 24, 1969 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- No Withdrawn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: