# Denka Seiken'S

- Location (FDA's records): Tokyo, JP
- FDA decisions: 4 (1998–2002): 4 510(k) clearances
- Product codes: MYI (1), DCN (1), GNA (1), DFC (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 3 (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
- DiaSorin, Inc.: 1 (https://510kreport.com/company/diasorin)

## Firms that cite its devices most
- Mast Group, Ltd.: 1 (https://510kreport.com/company/mast-group)
- General Atomics: 1 (https://510kreport.com/company/general-atomics)
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)

## Its most-cited devices
- K013359: LP (a)-Latex Seiken Assay Kit (2002), cited by 2
- K011400: Mrsa-Screen (2002), cited by 1

## Recent decisions
- K011400: Mrsa-Screen (Mar 27, 2002)
- K013359: LP (a)-Latex Seiken Assay Kit (Mar 8, 2002)
- K011958: CRP-Latex (II) Seiken High Sensitivity Assay Kit (Dec 4, 2001)
- K981734: Vtec-Rpla Seiken (Sep 22, 1998)

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