# KTL: Anti-Dna Indirect Immunofluorescent Solid Phase

- Device class: 2; regulation: 21 CFR 866.5100; FDA's rule: 510(k) required
- FDA decisions: 19
- 510(k) review time 2021–2025: median 494 days (middle half 292–696)
- 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)
- 1984: 4
- 1986: 2
- 1990: 1
- 1993: 1
- 1999: 1
- 2001: 1
- 2002: 1
- 2018: 2
- 2020: 1
- 2023: 2

## Most-cited predicates
- K930987: Crithidia Lucilliae DS Dna Kit (Diagnostic Use) (1993), cited by 1

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