AFINION ACR AND ACR CONTROL— 510(k) K072409

Substantially Equivalent

Axis-Shield Poc AS

FDA 510(k) clearance K072409 for AFINION ACR AND ACR CONTROL, Substantially Equivalent on 2008-02-12. Applicant: Axis-Shield Poc AS. Device class: 2.

Clearance details

Applicant: Axis-Shield Poc AS
Product code: Code JFY
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 2007-08-27
Decision date: 2008-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rodelokka, 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.