PMA supplement
P010007 S008: AFP IMMULITE SUBSTRATE REAGENT
FDA PMA supplement · 135 Review Track For 30-Day Notice · Siemens Healthcare Diagnostics, Inc.
Key facts
| Original PMA | P010007 |
|---|---|
| Supplement number | S008 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | AFP IMMULITE SUBSTRATE REAGENT |
| Generic name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Product code | LOK |
| Received date | Dec 19, 2011 |
| Decision date | Apr 5, 2012 |
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: