PMA
P040005: DAKOCYTOMATION HER2 FISH PHARMDX KIT
FDA PMA · System, Test, Her-2/Neu, Nucleic Acid Or Serum · Agilent Technologies Singapore (International) Pte, Ltd.
Key facts
| PMA number | P040005 |
|---|---|
| Trade name | DAKOCYTOMATION HER2 FISH PHARMDX KIT |
| Generic name | System, Test, Her-2/Neu, Nucleic Acid Or Serum |
| Applicant | Agilent Technologies Singapore (International) Pte , Ltd. |
| Owner/operator | Agilent Technologies, Inc |
| Product code | MVD |
| Approval date | May 3, 2005 |
| Docket number | 05M-0387 |
| Notice date | Sep 23, 2005 |
| Establishment registration | 3003423869 |
| FEI number | 3003423869 |
At a glance
- 10–99 Supplements
- Apr 12, 2017 Latest supplement decision
- No Withdrawn
- Yes 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: