PMA
P920048: FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)
FDA PMA · ENZYME IMMUNOASSAY, FETAL FIBRONECTIN · Hologic, Inc.
Key facts
| PMA number | P920048 |
|---|---|
| Trade name | FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK) |
| Generic name | ENZYME IMMUNOASSAY, FETAL FIBRONECTIN |
| Applicant | Hologic, Inc. |
| Owner/operator | HOLOGIC, INC. |
| Product code | LKV |
| Approval date | Sep 21, 1995 |
| Docket number | 96M-0218 |
| Notice date | Jul 8, 1996 |
| Establishment registration | 2024800 |
| FEI number | 2024800 |
At a glance
- 10–99 Supplements
- Aug 26, 2026 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- No Withdrawn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: