# PWD: Flow Cytometric Test System For Hematopoietic Neoplasms

- Device class: 2; regulation: 21 CFR 864.7010; 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)
- 2017: 1
- 2019: 1

## Most-cited predicates
- K183592: ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer (2019), cited by 1
- DEN160047: ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M (2017), cited by 1

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