# OUS: Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood  Culture Test Bt

- Device class: 1; regulation: 21 CFR 866.2050; FDA's rule: 510(k) required
- 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)
- 2011: 1
- 2012: 1

## Most-cited predicates
- K102342: Keypath (TM) Mrsa/Mssa Blood Culture Test- BT (2011), cited by 1

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