# P110030: Therascreen Kras RGQ PCR Kit

- Pathway: PMA
- Applicant: QIAGEN Manchester, Ltd.
- Decided: Jul 6, 2012 after 344 days
- Product code: OWD (Somatic Gene Mutation Detection System)
- Device class: 3
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

Source page: https://510kreport.com/device/P110030
Methodology: https://510kreport.com/methodology