PMA supplement
P970037 S001: AUTODELFIA HAFP TEST KIT
FDA PMA supplement · Special (Immediate Track) · Revvity, Inc.
Key facts
| Original PMA | P970037 |
|---|---|
| Supplement number | S001 |
| Supplement type | Special (Immediate Track) |
| Trade name | AUTODELFIA HAFP TEST KIT |
| Generic name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
| Applicant | Revvity, Inc. |
| Product code | LOK |
| Received date | Oct 18, 2002 |
| Decision date | Nov 27, 2002 |
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: