Cleared Dual Track

Afinion? HbA1c, Afinion? 2 and Alere Afinion? AS100 Analyzer

K214117 · Abbott Diagnostics Technologies AS · Chemistry

Sep 2023

Decision

636d

Days

Class 2

Risk

About This 510(k) Submission

K214117 is an FDA 510(k) clearance for the Afinion? HbA1c, Afinion? 2 and Alere Afinion? AS100 Analyzer, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Abbott Diagnostics Technologies AS (Oslo, NO). The FDA issued a Cleared decision on September 27, 2023, 636 days after receiving the submission on December 30, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number	K214117 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 30, 2021
Decision Date	September 27, 2023
Days to Decision	636 days
Submission Type	Dual Track
Review Panel	Chemistry (CH)
Summary	Summary PDF