s LDL-EX SEIKEN— 510(k) K161679

Substantially Equivalent

Denka Seiken Co., Ltd.

FDA 510(k) clearance K161679 for s LDL-EX SEIKEN, Substantially Equivalent on 2017-08-18. Applicant: Denka Seiken Co., Ltd..

Clearance details

Applicant: Denka Seiken Co., Ltd.
Product code: Code PYP
Advisory panel: Clinical Chemistry
Date received: 2016-06-17
Decision date: 2017-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gosen, JP

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