PMA supplement
P840027 S004: CEA-ROCHE(R) EIA
FDA PMA supplement · Normal 180 Day Track · Roche Diagnostics GmbH
Key facts
| Original PMA | P840027 |
|---|---|
| Supplement number | S004 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Other |
| Trade name | CEA-ROCHE(R) EIA |
| Generic name | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN |
| Applicant | Roche Diagnostics GmbH |
| Product code | DHX |
| Received date | Oct 27, 1988 |
| Decision date | Nov 29, 1988 |
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: