# PRH: Positive Blood Culture Identification And Ast Kit

- Device class: 2; regulation: 21 CFR 866.1650; FDA's rule: 510(k) required
- FDA decisions: 2
- Recalls: 3 (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)
- 2017: 1
- 2020: 1

## Most-cited predicates
- DEN160032: Accelerate Pheno system, Accelerate Phenotest BC Kit (2017), cited by 4
- K192665: Accelerate Pheno System, Accelerate PhenoTest BC Kit (2020), cited by 2

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