# Denka Seiken Co., Ltd.

- Location (FDA's records): Gosen-Shi, Niigata, JP
- FDA decisions: 6 (2003–2017): 6 510(k) clearances
- Product codes: JIT (1), JIS (1), LBS (1), PYP (1), DCK (1), MRR (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bayer Diagnostics Corp.: 2 (https://510kreport.com/company/bayer-diagnostics)
- Genzyme Corp.: 2 (https://510kreport.com/company/genzyme)
- Dade Behring, Inc.: 1 (https://510kreport.com/company/dade-behring)

## Firms that cite its devices most
- SENTINEL CH. SpA: 2 (https://510kreport.com/company/sentinel-ch)
- Ortho-Clinical Diagnostics, Inc.: 1 (https://510kreport.com/company/ortho-clinical-diagnostics)

## Its most-cited devices
- K060359: Archiect Insulin and Controls, Model 8K41-01, 8K41-10 (2006), cited by 1
- K030546: CRP (II) Calibrators (2003), cited by 1
- K030545: CRP-Latex (II)X2 Seiken Assay Kit (2003), cited by 1

## Recent decisions
- K161679: s LDL-EX SEIKEN (Aug 18, 2017)
- K060359: Archiect Insulin and Controls, Model 8K41-01, 8K41-10 (Apr 14, 2006)
- K043264: LDL-EX Seiken Assay Kit (Jan 26, 2005)
- K041090: HDL-EX Seiken Assay Kit (Oct 29, 2004)
- K030546: CRP (II) Calibrators (Jun 2, 2003)
- K030545: CRP-Latex (II)X2 Seiken Assay Kit (Jun 2, 2003)

Source page: https://510kreport.com/company/denka-seiken