# Roche Diagnostics Operations (Rdo)

- Location (FDA's records): Indianapolis, IN
- FDA decisions: 14 (2014–2020): 14 510(k) clearances
- Product codes: PDJ (2), DKB (1), DCN (1), KLT (1), LEH (1), JIQ (1), NDY (1), LBR (1), JIF (1), CJE (1), DDG (1), JHS (1)
- Predicates its devices cite: 14 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Diagnostics Corp.: 8 (https://510kreport.com/company/roche-diagnostics)
- Dade Behring, Inc.: 2 (https://510kreport.com/company/dade-behring)
- Boehringer Mannheim Corp.: 1 (https://510kreport.com/company/boehringer-mannheim)
- Beckman Coulter, Inc.: 1 (https://510kreport.com/company/beckman-coulter)
- Roche Diagnostic Systems, Inc.: 1 (https://510kreport.com/company/roche-diagnostic-systems)
- Genzyme Corp.: 1 (https://510kreport.com/company/genzyme)

## Firms that cite its devices most
- SENTINEL CH. SpA: 1 (https://510kreport.com/company/sentinel-ch)
- Siemens Healthcare Diagnostics, Inc.: 1 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Horiba Abx: 1 (https://510kreport.com/company/horiba-abx)

## Its most-cited devices
- K161817: Tina-quant Cystatin C Gen.2 (2016), cited by 1
- K171080: ALP IFCC Gen.2 (2017), cited by 1
- K160571: cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay (2016), cited by 1

## Recent decisions
- K193053: Tina-quant Hemoglobin A1cDx Gen.3 (Mar 26, 2020)
- K192072: Tina-quant C-Reactive Protein IV (Feb 21, 2020)
- K183517: Ammonia II (Feb 8, 2019)
- K182095: Tina-quant Transferrin ver.2 (urine application) (Nov 5, 2018)
- K171080: ALP IFCC Gen.2 (May 10, 2017)
- K160571: cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay (Dec 19, 2016)
- K162593: HDL-Cholesterol Gen.4 (Oct 19, 2016)
- K161817: Tina-quant Cystatin C Gen.2 (Jul 27, 2016)

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