OC-Light S FIT— 510(k) K143325

Substantially Equivalent

Eiken Chemical Co., Ltd.

FDA 510(k) clearance K143325 for OC-Light S FIT, Substantially Equivalent on 2015-08-20. Applicant: Eiken Chemical Co., Ltd..

Clearance details

Applicant: Eiken Chemical Co., Ltd.
Product code: Code KHE
Advisory panel: Hematology
Date received: 2014-11-20
Decision date: 2015-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taito-Ku, JP

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