PMA
P790032: GAMMA DAB (125I) AFP RIA KIT
FDA PMA · KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS · Incstar Corp.
Key facts
| PMA number | P790032 |
|---|---|
| Trade name | GAMMA DAB (125I) AFP RIA KIT |
| Generic name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
| Applicant | Incstar Corp. |
| Product code | LOK |
| Approval date | Apr 30, 1986 |
| Docket number | 86M-0206 |
| Notice date | Jun 17, 1986 |
At a glance
- 1–9 Supplements
- Jul 23, 1993 Latest supplement decision
- Yes Withdrawn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: