PMA
P980018: DAKO HERCEPTEST
FDA PMA · SYSTEM, TEST, HER-2/NEU, IHC · Agilent Technologies Singapore (International) Pte, Ltd.
Key facts
| PMA number | P980018 |
|---|---|
| Trade name | DAKO HERCEPTEST |
| Generic name | SYSTEM, TEST, HER-2/NEU, IHC |
| Applicant | Agilent Technologies Singapore (International) Pte , Ltd. |
| Owner/operator | Agilent Technologies, Inc |
| Product code | MVC |
| Approval date | Sep 25, 1998 |
| Docket number | 98M-0857 |
| Notice date | Oct 27, 1998 |
| Establishment registration | 3003423869 |
| FEI number | 3003423869 |
At a glance
- 10–99 Supplements
- Sep 21, 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- No Withdrawn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: