# KLN: Radioimmunoassay, Cocaine Metabolite

- Device class: 2; regulation: 21 CFR 862.3250; FDA's rule: 510(k) required
- FDA decisions: 14
- 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
- 1986: 1
- 1987: 2
- 1988: 1
- 1990: 1
- 1991: 7
- 2001: 1

## Most-cited predicates
- K870740: Coat-a-Count Cocaine Metabolite TKCN1 & TKCN5 (1987), cited by 1
- K010868: Psychemedics Ria Cocaine Assay (2001), cited by 1

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