# GNY: Antisera, Fluorescent, Adenovirus 1-33

- Device class: 1; regulation: 21 CFR 866.3020; FDA's rule: 510(k) exempt
- FDA decisions: 4
- 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)
- 1977: 2
- 1989: 1
- 1993: 1

## Most-cited predicates
- K922801: Resp. Panel 1 Indirect Immunofluorescence Assay (1993), cited by 1

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