# LSK: Dna-Reagents, Chlamydia

- Device class: 1; regulation: 21 CFR 866.3120; FDA's rule: 510(k) required
- FDA decisions: 8
- Recalls: 1 (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)
- 1987: 2
- 1992: 1
- 1994: 1
- 1999: 1
- 2001: 2
- 2010: 1

## Most-cited predicates
- K092704: Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection Kit, Models 8L07-91, 9K12-03 (2010), cited by 1

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