PMA supplement
P800005 S004: ANTI-CARCINOEMBRYONIC ANTIGEN (GOAT) CEA RIA
FDA PMA supplement · Abbott Laboratories
Key facts
| Original PMA | P800005 |
|---|---|
| Supplement number | S004 |
| Trade name | ANTI-CARCINOEMBRYONIC ANTIGEN (GOAT) CEA RIA |
| Generic name | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN |
| Applicant | Abbott Laboratories |
| Product code | DHX |
| Received date | Mar 2, 1982 |
| Decision date | Mar 29, 1982 |
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: