OC-Auto SENSOR io iFOB Test— 510(k) K191147

Substantially Equivalent

Eiken Chemical Co., Ltd.

FDA 510(k) clearance K191147 for OC-Auto SENSOR io iFOB Test, Substantially Equivalent on 2020-01-02. Applicant: Eiken Chemical Co., Ltd..

Clearance details

Applicant: Eiken Chemical Co., Ltd.
Product code: Code OOX
Advisory panel: Hematology
Date received: 2019-04-30
Decision date: 2020-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taito-Ku, JP

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