Afinion HbA1c Dx on Afinion 2— 510(k) K182988

Substantially Equivalent

Alere Technologies AS

FDA 510(k) clearance K182988 for Afinion HbA1c Dx on Afinion 2, Substantially Equivalent on 2018-11-29. Applicant: Alere Technologies AS.

Clearance details

Applicant: Alere Technologies AS
Product code: Code PDJ
Advisory panel: Clinical Chemistry
Date received: 2018-10-29
Decision date: 2018-11-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Oslo, NO

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