# KQP: Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase

- Device class: 2; regulation: 21 CFR 862.1315; FDA's rule: 510(k) required
- FDA decisions: 7
- Recalls: 1 (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)
- 1990: 1
- 1997: 1
- 1999: 2
- 2010: 1
- 2011: 2

## Most-cited predicates
- K990827: Microplate Neonatal Galt Assay (1999), cited by 3

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