# P980018: Dako Herceptest

- Pathway: PMA
- Applicant: Agilent Technologies Singapore (International) Pte, Ltd.
- Decided: Sep 25, 1998 after 130 days
- Product code: MVC (System, Test, Her-2/Neu, Ihc)
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K023335: QCS HER2 Immunocontrols (Product NO. C010) (2003), 1 descendant of its own
- K220163: Her-2, ER, PR IHControls (2022), 0 descendants of its own

## Recalls of this device
- Sep 29, 2005 · Not classified · Z-0113-06: Formulation error in the Visualization Reagent (vial 3) component contained in Hercep Test kits. The error was in the concentration of Polyethylene Glycol contained in the formulation.

Source page: https://510kreport.com/device/P980018
Methodology: https://510kreport.com/methodology