PMA supplement
P930036 S018: Atellica® IM Alpha Fetoprotein (AFP) Assay
FDA PMA supplement · Real-Time Process · Siemens Healthcare Diagnostics, Inc.
Key facts
| Original PMA | P930036 |
|---|---|
| Supplement number | S018 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Atellica® IM Alpha Fetoprotein (AFP) Assay |
| Generic name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Product code | LOK |
| Received date | Aug 11, 2021 |
| Decision date | Nov 9, 2021 |
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: