PMA supplement
P980041 S010: IN VITRO DIAGNOSTIC PRODUCT ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
FDA PMA supplement · Real-Time Process · Beckman Coulter, Inc.
Key facts
| Original PMA | P980041 |
|---|---|
| Supplement number | S010 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | IN VITRO DIAGNOSTIC PRODUCT ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS |
| Generic name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
| Applicant | Beckman Coulter, Inc. |
| Product code | LOK |
| Received date | Sep 7, 2007 |
| Decision date | Nov 27, 2007 |
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: