# JBY: Aggregometer, Platelet, Photo-Optical Scanning

- Device class: 2; regulation: 21 CFR 864.6675; 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)
- 1977: 1
- 1991: 1

## Most-cited predicates
- K771198: Lumi-Aggregometer (1977), cited by 2

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