# LQF: Dna-Reagents, Mycobacterium Spp.

- Device class: 1; regulation: 21 CFR 866.3370; FDA's rule: 510(k) required
- FDA decisions: 15
- Recalls: 2 (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: 3
- 1987: 2
- 1989: 1
- 1990: 8
- 1992: 1

## Most-cited predicates

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