# NDR: Enzyme Immunoassay, Inhibin-A

- Device class: 1; regulation: 21 CFR 862.1260; FDA's rule: 510(k) exempt
- FDA decisions: 1
- Recalls: 3 (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)
- 2000: 1

## Most-cited predicates
- K002128: Active Inhibin-a Elisa, Model DSL-10-28100 (2000), cited by 1

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