AFINION ANALYZER— 510(k) K110056

Substantially Equivalent

Axis-Shield Poc AS

FDA 510(k) clearance K110056 for AFINION ANALYZER, Substantially Equivalent on 2011-02-15. Applicant: Axis-Shield Poc AS. Device class: 2.

Clearance details

Applicant: Axis-Shield Poc AS
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2011-01-10
Decision date: 2011-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oslo, NO

Download summary PDF View on FDA.gov ↗

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