PMA
N50538: FLOW MIC SYSTEM
FDA PMA · SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION · Flow Laboratories, Inc.
Key facts
| PMA number | N50538 |
|---|---|
| Trade name | FLOW MIC SYSTEM |
| Generic name | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION |
| Applicant | Flow Laboratories, Inc. |
| Product code | LON |
| Approval date | Jul 15, 1980 |
| Notice date | Nov 20, 1980 |
At a glance
- 1–9 Supplements
- Apr 17, 1981 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- No Withdrawn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: