# Roche Professional Diagnostics

- Location (FDA's records): Indianapolis, IN
- FDA decisions: 2 (2010–2015): 2 510(k) clearances
- Product codes: LOL (1), LTK (1)
- Predicates its devices cite: 3 (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
- Abbott Laboratories: 1 (https://510kreport.com/company/abbott-laboratories)
- Boehringer Mannheim Corp.: 1 (https://510kreport.com/company/boehringer-mannheim)
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)

## Firms that cite its devices most
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)

## Its most-cited devices
- K100903: Anti-Hav (2010), cited by 1

## Recent decisions
- K143534: Elecsys CA-125 II assay (Aug 6, 2015)
- K100903: Anti-Hav (Oct 5, 2010)

Source page: https://510kreport.com/company/roche-professional-diagnostics