PMA
P930027: IMMULITE SYSTEMS PSA & THIRD GENERATION PSA REAGENTS
FDA PMA · Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer · Siemens Healthcare Diagnostics, Inc.
Key facts
| PMA number | P930027 |
|---|---|
| Trade name | IMMULITE SYSTEMS PSA & THIRD GENERATION PSA REAGENTS |
| Generic name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Product code | MTF |
| Approval date | Sep 15, 1995 |
| Docket number | 96M-0217 |
| Notice date | Sep 12, 1996 |
| Establishment registration | 3009448641 |
| FEI number | 3009448641 |
At a glance
- 10–99 Supplements
- Sep 22, 2026 Latest supplement decision
- No Withdrawn
- No 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: