# DLG: Coating, Liquid, Glc

- Device class: 1; regulation: 21 CFR 862.2250; FDA's rule: 510(k) exempt
- FDA decisions: 7
- 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)
- 1983: 1
- 1988: 1
- 1989: 3
- 1992: 1
- 2006: 1

## Most-cited predicates
- K050988: Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and Controls (2006), cited by 2

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