PMA
P050045: DAKO TOP2A FISH PHARMDX KIT
FDA PMA · Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion · Dako Denmark A/S
Key facts
| PMA number | P050045 |
|---|---|
| Trade name | DAKO TOP2A FISH PHARMDX KIT |
| Generic name | Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion |
| Applicant | Dako Denmark A/S |
| Product code | NXG |
| Approval date | Jan 11, 2008 |
| Docket number | 08M-0182 |
| Notice date | Mar 20, 2008 |
At a glance
- 1–9 Supplements
- Jun 1, 2012 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: