# DEN130010: Vysis EGR1 Fish Probe Kit - SC (Specimen Characterization)

- Pathway: De Novo (Post-NSE)
- Applicant: Abbott Molecular, Inc.
- Decided: Jul 29, 2013 after 111 days
- Product code: PDO (Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization)
- Device class: 2
- Regulation: 21 CFR 864.1870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K131508: Vysis D7S486/Cep 7 Fish Probe Kit (2013), 0 descendants of its own

Source page: https://510kreport.com/device/DEN130010
Methodology: https://510kreport.com/methodology