# DLZ: Enzyme Immunoassay, Phenobarbital

- Device class: 2; regulation: 21 CFR 862.3660; FDA's rule: 510(k) required
- FDA decisions: 35
- 510(k) review time 2021–2025: median 143 days (middle half 143–143)
- Recalls: 7 (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)
- 1991: 2
- 1994: 3
- 1995: 2
- 1999: 1
- 2000: 2
- 2001: 2
- 2007: 1
- 2008: 1
- 2013: 1
- 2021: 1

## Most-cited predicates
- K984288: Vitros Chemistry Products PHBR Slides (1999), cited by 2
- K913190: Emit (R) 2000 Phenobarbital Assay/Calibrators (1991), cited by 1
- K946210: Phenobarbital Enzyme Immunoassay (1995), cited by 1
- K944932: Phenobarbital Flex Reagent Cartridge (1994), cited by 1
- K993031: Abbott Aeroset Phenobarbital Assey and Calibrators;Models 1E08 and 5F54 (2000), cited by 1
- K081231: Architect Iphenobarbital Reagents and Architect Iphenobarbital Calibrators, Models 1P33, 1P33 (2008), cited by 1

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