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.. Device class: 1.

Clearance details

Applicant: Denka Seiken Co., Ltd.
Product code: Code PYP
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 2016-06-17
Decision date: 2017-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gosen, JP

Download summary PDF View on FDA.gov ↗

More clearances from Denka Seiken Co., Ltd.

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K043264 — LDL-EX SEIKEN ASSAY KIT2005-01-26
K041090 — HDL-EX SEIKEN ASSAY KIT2004-10-29
K030545 — CRP-LATEX (II)X2 SEIKEN ASSAY KIT2003-06-02
K030546 — CRP (II) CALIBRATORS2003-06-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.