# JNM: Immunochemical, Transferrin

- Device class: 2; regulation: 21 CFR 866.5880; FDA's rule: 510(k) required
- FDA decisions: 3
- 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)
- 1997: 1
- 1998: 1
- 1999: 1

## Most-cited predicates
- K970718: Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa) (1997), cited by 4

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