PMA supplement
P800063 S001: CEA-ROCHE TEST KIT
FDA PMA supplement · Hoffmann-La Roche, Inc.
Key facts
| Original PMA | P800063 |
|---|---|
| Supplement number | S001 |
| Trade name | CEA-ROCHE TEST KIT |
| Generic name | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN |
| Applicant | Hoffmann-La Roche, Inc. |
| Product code | DHX |
| Received date | Sep 11, 1981 |
| Decision date | Mar 3, 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: