Afinion HbA1c Dx— 510(k) K180296

Substantially Equivalent

Alere Technologies AS

FDA 510(k) clearance K180296 for Afinion HbA1c Dx, Substantially Equivalent on 2018-05-07. Applicant: Alere Technologies AS.

Clearance details

Applicant: Alere Technologies AS
Product code: Code PDJ
Advisory panel: Clinical Chemistry
Date received: 2018-02-02
Decision date: 2018-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oslo, NO

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