# Eiken Chemical Co., Ltd.

- Location (FDA's records): Taito-Ku, JP
- FDA decisions: 4 (1985–2020): 4 510(k) clearances
- Names in FDA's records: Eiken Chemical Co., Ltd. (2); Eiken Chemical Co., Inc. (2)
- Product codes: KHE (1), OOX (1), CFN (1), JJE (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (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
- Polymedco, Inc.: 1 (https://510kreport.com/company/polymedco)
- Polymedco Cancer Diagnostics, LLC: 1 (https://510kreport.com/company/polymedco-cancer-diagnostics)

## Recent decisions
- K191147: OC-Auto SENSOR io iFOB Test (Jan 2, 2020)
- K143325: OC-Light S FIT (Aug 20, 2015)
- K864342: Multipurpose Immunochemistry System LA-2000 Latex (Dec 1, 1986)
- K853391: Multipurpose Immunochemistry Sys-LA-2000 (Oct 1, 1985)

Source page: https://510kreport.com/company/eiken-chemical