# Labone, Inc.

- Location (FDA's records): Lenexa, KS
- FDA decisions: 2 (2004–2004): 2 510(k) clearances
- Product codes: DIO (1), DLJ (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- OraSure Technologies, Inc.: 2 (https://510kreport.com/company/orasure-technologies)

## Firms that cite its devices most
- Healgen Scientific,, LLC: 1 (https://510kreport.com/company/healgen-scientific)

## Its most-cited devices
- K033601: Labone Micro-Plate Cotinine Eia (2004), cited by 1

## Recent decisions
- K040198: Labone Cocaine Metabolite Micro-Plate Eia (Mar 5, 2004)
- K033601: Labone Micro-Plate Cotinine Eia (Feb 10, 2004)

Source page: https://510kreport.com/company/labone