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

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.

Clearance details

Applicant: Alere Technologies AS
Product code: Code LCP
Advisory panel: Hematology
Date received: 2015-07-02
Decision date: 2015-09-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Oslo, NO

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