# CFQ: Radioimmunoassay, Immunoglobulins (G, A, M)

- Device class: 2; regulation: 21 CFR 866.5510; FDA's rule: 510(k) required
- FDA decisions: 12
- 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)
- 1988: 3
- 1989: 2
- 1995: 3
- 1999: 4

## Most-cited predicates
- K950900: Olympus Igm Immunoturbidimetric Reagent (1995), cited by 1
- K951013: Olympus Igg Immunoturbidimetric Reagent (1995), cited by 1
- K951055: Olympus Iga Immunoturbidimetric Reagent (1995), cited by 1
- K990551: Igg Flex Reagent Cartridge (1999), cited by 1

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