CRP (II) CALIBRATORS— 510(k) K030546

Substantially Equivalent

Denka Seiken Co., Ltd.

FDA 510(k) clearance K030546 for CRP (II) CALIBRATORS, Substantially Equivalent on 2003-06-02. Applicant: Denka Seiken Co., Ltd.. Device class: 2.

Clearance details

Applicant: Denka Seiken Co., Ltd.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 2003-02-20
Decision date: 2003-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gosen City, Niigata, JP

Download summary PDF View on FDA.gov ↗

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