PMA
P840027: CEA-ROCHE(R) EIA
FDA PMA · SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN · Roche Diagnostics GmbH
Key facts
| PMA number | P840027 |
|---|---|
| Trade name | CEA-ROCHE(R) EIA |
| Generic name | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN |
| Applicant | Roche Diagnostics GmbH |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | DHX |
| Approval date | May 13, 1985 |
| Docket number | 85M-0253 |
| Notice date | Jun 12, 1985 |
| Establishment registration | 2243471 |
| FEI number | 2243471 |
At a glance
- 1–9 Supplements
- May 1, 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- Yes Withdrawn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: