Alere Afinion HbA1c, Alere Afinion AS100 Analyzer— 510(k) K151809

Name: FDA 510(k) clearance K151809
Creator: U.S. Food and Drug Administration
Published: 2015-09-25

Substantially Equivalent

Alere Technologies AS

FDA 510(k) clearance K151809 for Alere Afinion HbA1c, Alere Afinion AS100 Analyzer, Substantially Equivalent on 2015-09-25. Applicant: Alere Technologies AS. Device class: 2.

Clearance details

Applicant: Alere Technologies AS
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2015-07-02
Decision date: 2015-09-25
Decision: Substantially Equivalent
Clearance type: Special
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.