PMA
P110030: THERASCREEN KRAS RGQ PCR KIT
FDA PMA · Somatic gene mutation detection system · QIAGEN Manchester, Ltd.
Key facts
| PMA number | P110030 |
|---|---|
| Trade name | THERASCREEN KRAS RGQ PCR KIT |
| Generic name | Somatic gene mutation detection system |
| Applicant | QIAGEN Manchester, Ltd. |
| Owner/operator | QIAGEN, GmbH |
| Product code | OWD |
| Approval date | Jul 6, 2012 |
| Docket number | 12M-0735 |
| Notice date | Jul 16, 2012 |
| Establishment registration | 3004013603 |
| FEI number | 3004013603 |
At a glance
- None Supplements
- Jul 6, 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- Yes Withdrawn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: