# DIP: Enzyme Immunoassay, Diphenylhydantoin

- Device class: 2; regulation: 21 CFR 862.3350; FDA's rule: 510(k) required
- FDA decisions: 44
- Recalls: 9 (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)
- 1993: 1
- 1994: 2
- 1995: 2
- 1996: 1
- 1997: 1
- 2000: 2
- 2001: 2
- 2003: 1
- 2007: 1
- 2008: 1

## Most-cited predicates
- K905689: Cedia Phenytoin Assay (1991), cited by 2
- K913429: Emit (R) 2000 Phenytoin Assay/Calibrators (1991), cited by 1
- K963840: Cedia Phenytoin II Assay (1996), cited by 1
- K945725: Phenytion Eia Test (1995), cited by 1
- K911056: DU Pont Dimension (R) Phenytoin (PTN) Method (1991), cited by 1
- K941142: Kodak Ektachem Clinical Chemistry Slide Phenytoin (1994), cited by 1

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