PMA
P050040: SPOT-LIGHT HER2 CISH KIT
FDA PMA · Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer · Invitrogen Corporation
Key facts
| PMA number | P050040 |
|---|---|
| Trade name | SPOT-LIGHT HER2 CISH KIT |
| Generic name | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer |
| Applicant | Invitrogen Corporation |
| Owner/operator | Life Technologies Corporation |
| Product code | NYQ |
| Approval date | Jul 1, 2008 |
| Docket number | 08M-0437 |
| Notice date | Jul 31, 2008 |
| Establishment registration | 1317268 |
| FEI number | 1317268 |
At a glance
- 1–9 Supplements
- Jul 6, 2012 Latest supplement decision
- Yes Withdrawn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: