PMA
P780006: AMERSHAM AFP
FDA PMA · KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS · Ortho Clinical Diagnostics
Key facts
| PMA number | P780006 |
|---|---|
| Trade name | AMERSHAM AFP |
| Generic name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
| Applicant | Ortho Clinical Diagnostics |
| Owner/operator | QuidelOrtho Corporation |
| Product code | LOK |
| Approval date | Jun 7, 1984 |
| Docket number | 84M-0227 |
| Notice date | Jul 6, 1984 |
| Establishment registration | 1319681 |
| FEI number | 1000136573 |
At a glance
- 1–9 Supplements
- Sep 26, 1989 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- Yes Withdrawn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: