# PQZ: Gbs Culture Media, Selective And Differential

- Device class: 1; regulation: 21 CFR 866.2360; FDA's rule: 510(k) required
- FDA decisions: 4
- Recalls: 2 (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: 3
- 2018: 1

## Most-cited predicates
- K163042: chromID Strepto B agar (2017), cited by 1

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