PMA supplement
P780006 S002: AMERSHAM AFP
FDA PMA supplement · Ortho Clinical Diagnostics
Key facts
| Original PMA | P780006 |
|---|---|
| Supplement number | S002 |
| Trade name | AMERSHAM AFP |
| Generic name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
| Applicant | Ortho Clinical Diagnostics |
| Product code | LOK |
| Received date | Oct 31, 1985 |
| Decision date | Mar 17, 1986 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: