# P050040: Spot-Light HER2 Cish Kit

- Pathway: PMA
- Applicant: Invitrogen Corporation
- Decided: Jul 1, 2008 after 971 days
- Product code: NYQ (Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Nov 14, 2011 · Not classified · Z-0461-2012: In vitro diagnostic reagent may be contaminated with a fungal contaminant.

Source page: https://510kreport.com/device/P050040
Methodology: https://510kreport.com/methodology