# P110012: Vysis Alk Break Apart Fish Probe Kit, Vysis Paraffin Pretreatment IV & Post Hybridization Wash Buffer Kit Probechek Alk

- Pathway: PMA
- Applicant: Abbott Molecular, Inc.
- Decided: Aug 26, 2011 after 147 days
- Product code: OWE (Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement)
- 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/P110012
Methodology: https://510kreport.com/methodology