PMA
P980041: ACCESS AFP IMMUNOASSAY SYSTEM
FDA PMA · KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS · Beckman Coulter, Inc.
Key facts
| PMA number | P980041 |
|---|---|
| Trade name | ACCESS AFP IMMUNOASSAY SYSTEM |
| Generic name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
| Applicant | Beckman Coulter, Inc. |
| Owner/operator | BECKMAN COULTER, INC. |
| Product code | LOK |
| Approval date | Feb 8, 1999 |
| Docket number | 99M-0793 |
| Notice date | Apr 8, 1999 |
| Establishment registration | 2122870 |
| FEI number | 2122870 |
At a glance
- 10–99 Supplements
- Nov 3, 2025 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- No Withdrawn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: