PMA
P060005: IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS
FDA PMA · Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions · Siemens Medical Solutions Diagnostics Limited
Key facts
| PMA number | P060005 |
|---|---|
| Trade name | IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS |
| Generic name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
| Applicant | Siemens Medical Solutions Diagnostics Limited |
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Product code | MTG |
| Approval date | May 11, 2007 |
| Docket number | 07M-0409 |
| Notice date | Nov 9, 2007 |
| Establishment registration | 2432235 |
| FEI number | 2432235 |
At a glance
- 10–99 Supplements
- Sep 22, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: