PMA supplement
P010007 S010: IMMULITE/IMMULITE 1000 AFP and IMMULITE 2000 AFP
FDA PMA supplement · Real-Time Process · Siemens Healthcare Diagnostics, Inc.
Key facts
| Original PMA | P010007 |
|---|---|
| Supplement number | S010 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | IMMULITE/IMMULITE 1000 AFP and IMMULITE 2000 AFP |
| Generic name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Product code | LOK |
| Received date | Sep 28, 2018 |
| Decision date | Dec 27, 2018 |
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: