PMA
P970037: AUTODELFIA HAFP TEST KIT
FDA PMA · KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS · Revvity, Inc.
Key facts
| PMA number | P970037 |
|---|---|
| Trade name | AUTODELFIA HAFP TEST KIT |
| Generic name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
| Applicant | Revvity, Inc. |
| Product code | LOK |
| Approval date | Mar 31, 1998 |
| Docket number | 98M-0306 |
| Notice date | May 27, 1998 |
At a glance
- 10–99 Supplements
- Aug 11, 2021 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: