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510(k) K180296

Afinion HbA1c Dx by Alere Technologies AS — Product Code PDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2018
Date Received
February 2, 2018
Clearance Type
Traditional
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

  • K182988 — Afinion HbA1c Dx on Afinion 2 (November 29, 2018)
  • K151809 — Alere Afinion HbA1c, Alere Afinion AS100 Analyzer (September 25, 2015)

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  • K200904 — Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 (August 5, 2021)
  • K200256 — ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay (July 2, 2021)
  • K193053 — Tina-quant Hemoglobin A1cDx Gen.3 (March 26, 2020)
  • K182651 — HbA1c Advanced (January 16, 2019)
  • K182988 — Afinion HbA1c Dx on Afinion 2 (November 29, 2018)
  • K173909 — Dimension Hemoglobin A1c Assay (July 13, 2018)