PMA supplement
P850048 S044: ACCESS PSA CALIBRATORS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA PMA supplement · 30-Day Notice · Beckman Coulter, Inc.
Key facts
| Original PMA | P850048 |
|---|---|
| Supplement number | S044 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | ACCESS PSA CALIBRATORS ON THE ACCESS IMMUNOASSAY ANALYZER |
| Generic name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
| Applicant | Beckman Coulter, Inc. |
| Product code | MTF |
| Received date | Jan 17, 2017 |
| Decision date | Feb 14, 2017 |
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: