PMA
P820073: MICUR-MIC SYSTEMS
FDA PMA · SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION · Boehringer Mannheim Corp.
Key facts
| PMA number | P820073 |
|---|---|
| Trade name | MICUR-MIC SYSTEMS |
| Generic name | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION |
| Applicant | Boehringer Mannheim Corp. |
| Product code | LON |
| Approval date | Jun 29, 1983 |
| Docket number | 83M-0226 |
| Notice date | Jul 19, 1983 |
At a glance
- None Supplements
- Jun 29, 1983 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- No Withdrawn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: