# MCE: Respiratory Syncytial Virus - Elisa

- Device class: 1; regulation: 21 CFR 866.3480; FDA's rule: 510(k) exempt
- FDA decisions: 2
- 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)
- 1993: 1
- 2006: 1

## Most-cited predicates
- K061008: Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199 (2006), cited by 2

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