PMA
P810007: JAUNDICE METER 101
FDA PMA · Meter, jaundice · Narco Scientific
Key facts
| PMA number | P810007 |
|---|---|
| Trade name | JAUNDICE METER 101 |
| Generic name | Meter, jaundice |
| Applicant | Narco Scientific |
| Product code | LMX |
| Approval date | Nov 20, 1981 |
| Docket number | 81M-0383 |
| Notice date | Dec 18, 1981 |
At a glance
- None Supplements
- Nov 20, 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- No Withdrawn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: