PMA
P810024: AUTOBAC MTS PLUS TEST SYTEM
FDA PMA · SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION · Warner-Lambert Co.
Key facts
| PMA number | P810024 |
|---|---|
| Trade name | AUTOBAC MTS PLUS TEST SYTEM |
| Generic name | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION |
| Applicant | Warner-Lambert Co. |
| Product code | LON |
| Approval date | Mar 4, 1982 |
| Docket number | 82M-0070 |
| Notice date | Mar 26, 1982 |
| FEI number | 1811098 |
At a glance
- 1–9 Supplements
- Apr 12, 1988 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- No Withdrawn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: