# OAV: Mycophenolic Acid Test System

- Device class: 2; regulation: 21 CFR 862.3840; FDA's rule: 510(k) required
- FDA decisions: 3
- 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)
- 2007: 1
- 2008: 1
- 2011: 1

## Most-cited predicates
- K063520: Roche Total Mycophenolic Acid Assay, Calibrators and Controls (2007), cited by 2

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