AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL— 510(k) K132031

Substantially Equivalent

Axis-Shield Poc AS

FDA 510(k) clearance K132031 for AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL, Substantially Equivalent on 2014-03-21. Applicant: Axis-Shield Poc AS.

Clearance details

Applicant: Axis-Shield Poc AS
Product code: Code CHH
Advisory panel: Clinical Chemistry
Date received: 2013-07-18
Decision date: 2014-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oslo, NO

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