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510(k) K182988

Afinion HbA1c Dx on Afinion 2 by Alere Technologies AS — Product Code PDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2018
Date Received
October 29, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemoglobin A1c Test System
Device Class
Class II
Regulation Number
862.1373
Review Panel
CH
Submission Type

Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.

Other clearances by Alere Technologies AS

  • K180296 — Afinion HbA1c Dx (May 7, 2018)
  • K151809 — Alere Afinion HbA1c, Alere Afinion AS100 Analyzer (September 25, 2015)

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