PMA supplement
P980041 S001: ACCESS AFP ASSAY ON THE ACCESS 2 IMMUNOASSAY SYSTEMS
FDA PMA supplement · Normal 180 Day Track · Beckman Coulter, Inc.
Key facts
| Original PMA | P980041 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | ACCESS AFP ASSAY ON THE ACCESS 2 IMMUNOASSAY SYSTEMS |
| Generic name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
| Applicant | Beckman Coulter, Inc. |
| Product code | LOK |
| Received date | Jun 18, 2002 |
| Decision date | Oct 1, 2002 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: