DUET SYSTEM— 510(k) K130775

Substantially Equivalent

Bioview , Ltd.

FDA 510(k) clearance K130775 for DUET SYSTEM, Substantially Equivalent on 2014-05-09. Applicant: Bioview , Ltd.. Device class: 2.

Clearance details

Applicant: Bioview , Ltd.
Product code: Code NTH
Device class: Class 2
Regulation: 21 CFR 866.4700
Advisory panel: Immunology
Date received: 2013-03-20
Decision date: 2014-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kfar Saba, IL

Download summary PDF View on FDA.gov ↗

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