# GNM: Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6

- Device class: 1; regulation: 21 CFR 866.3145; FDA's rule: 510(k) exempt
- FDA decisions: 9
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1995: 9

## Most-cited predicates

Source page: https://510kreport.com/product-code/GNM
Data by year (CSV): https://510kreport.com/product-code/GNM.csv