PMA
P800030: BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC
FDA PMA · SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION · Bd Becton Dickinson Vacutainer Systems Preanalytic
Key facts
| PMA number | P800030 |
|---|---|
| Trade name | BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC |
| Generic name | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION |
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| Owner/operator | Becton Dickinson and Company |
| Product code | LON |
| Approval date | Feb 18, 1981 |
| Notice date | Mar 17, 1981 |
| Establishment registration | 1917413 |
| FEI number | 1917413 |
At a glance
- 1–9 Supplements
- Nov 5, 1984 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- No Withdrawn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: