510(k) Report

FDA applicant

Alere Technologies AS

Oslo, NO3 decisions2015–20181 recall

FDA records 3 decisions for Alere Technologies AS (Oslo, NO) from 2015 to 2018: 3 510(k) clearances. Most are in product codes PDJ (Hemoglobin A1c Test System) and LCP (Assay, Glycosylated Hemoglobin). Its devices cite 4 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Alere Technologies AS’s devices, and how often a recall has named them.

FDA decisions per year

2in 2018

2015: 12018: 2
2015high 2 (2018) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2020

2020: 1
2015high 1 (2020) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Alere Technologies AS by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PDJHemoglobin A1c Test System2decisions
  • LCPAssay, Glycosylated Hemoglobin1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K151809Alere Afinion HbA1c, Alere Afinion AS100 AnalyzerAlere Technologies AS · 20155cite it
  • K180296Afinion HbA1c DxAlere Technologies AS · 20181cites it

What has FDA decided for it lately?

  • K182988Afinion HbA1c Dx on Afinion 2Alere Technologies AS · 20181 recall
  • K180296Afinion HbA1c DxAlere Technologies AS · 20181 recall
  • K151809Alere Afinion HbA1c, Alere Afinion AS100 AnalyzerAlere Technologies AS · 2015

All 3 as Alere Technologies AS →

What has been recalled?

1 recall linked to its devices; the latest:

  • K182988Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556…Mar 23, 2020Class II

Other applicant names beginning “Alere”

FDA records each applicant name separately; these may or may not be the same firm.

Alere Scarborough, Inc. 17Alere Scarborough, Inc D/B/A Binax, Inc. 4Alere San Diego, Inc. 2Alere, San Diego, Dba Biosite INcorporated, Dba IN 1Alere, Inc. 1Alere San Diego, Inc (Formally Biosite Incorporate 1Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen 1