PMA
P900042: AWARE TEST SYSTEM
FDA PMA · TEST SYSTEM, FOR DRUGS OF ABUSE · American Drug Screens, Inc.
Key facts
| PMA number | P900042 |
|---|---|
| Trade name | AWARE TEST SYSTEM |
| Generic name | TEST SYSTEM, FOR DRUGS OF ABUSE |
| Applicant | American Drug Screens, Inc. |
| Product code | MGX |
| Approval date | Jan 18, 1994 |
| Docket number | 94M-0067 |
| Notice date | Apr 19, 1994 |
At a glance
- None Supplements
- Jan 18, 1994 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- No Withdrawn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: