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. Device class: 2.

Clearance details

Applicant: Alere Technologies AS
Product code: Code PDJ
Device class: Class 2
Regulation: 21 CFR 862.1373
Advisory panel: Clinical Chemistry
Date received: 2018-02-02
Decision date: 2018-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oslo, NO

Download summary PDF View on FDA.gov ↗

Recent devices under product code PDJ

K252749 — Medconn 8K Glycated Hemoglobin Test System2026-01-06
K250073 — Tosoh Automated Glycohemoglobin Analyzer HLC-723GR012025-10-03
K242911 — Medconn Glycated Hemoglobin Test system2025-06-20
K220999 — Hipro Glycosylated Hemoglobin (HbA1c) Test System2024-09-12
K200904 — Tosoh Automated Glycohemoglobin Analyzer HLC-723G82021-08-05

More clearances from Alere Technologies AS

K182988 — Afinion HbA1c Dx on Afinion 22018-11-29
K151809 — Alere Afinion HbA1c, Alere Afinion AS100 Analyzer2015-09-25

Recalls naming K180296

K-number listed on FDA's recall record

Z-2192-2020 — Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, 1116970, 1116971, 1116985, 1116986, IVD. The firm name on the label is Abbott Diagnostics Technologies AS, Oslo, Norway. Power supply provided with Alere Afinion AS100 Analyzer, Catalog numbers 1115175, 1115390, 1116049, 1116050, 1116053, 1116054, 1116456, and 1116980. The firm name on the label is Alere Technologies AS, Oslo, Norway.Class II·Ongoing·Abbott Diagnostics Technologies AS·20200323

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180296.

Data sourced from openFDA. This site is unofficial and independent of the FDA.