PMA
P010007: IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP
FDA PMA · KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS · Siemens Healthcare Diagnostics, Inc.
Key facts
| PMA number | P010007 |
|---|---|
| Trade name | IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP |
| Generic name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Product code | LOK |
| Approval date | Nov 9, 2001 |
| Docket number | 01M-0537 |
| Notice date | Dec 5, 2001 |
| 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- No Withdrawn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: