PMA
P000027: ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK
FDA PMA · PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS · Roche Diagnostics Corp.
Key facts
| PMA number | P000027 |
|---|---|
| Trade name | ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK |
| Generic name | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
| Applicant | Roche Diagnostics Corp. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | LTJ |
| Approval date | Dec 12, 2000 |
| Docket number | 00M-1683 |
| Notice date | Jan 3, 2001 |
| Establishment registration | 9610529 |
| FEI number | 3002806560 |
At a glance
- 10–99 Supplements
- Apr 29, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: