# LQL: Gram Positive Identification Panel

- Device class: 1; regulation: 21 CFR 866.2660; FDA's rule: 510(k) exempt
- FDA decisions: 11
- 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)
- 1986: 1
- 1988: 1
- 1989: 1
- 1990: 1
- 1991: 2
- 1993: 1
- 1996: 1
- 1997: 2
- 1998: 1

## Most-cited predicates
- K910304: Rapid Coryne Syst/Identif of Coryneform Bacteria (1991), cited by 1

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