510(k) Report

FDA applicant

Axis-Shield Poc AS

Oslo, NO4 decisions2005–20140 recalls

FDA records 4 decisions for Axis-Shield Poc AS (Oslo, NO) from 2005 to 2014: 4 510(k) clearances. Most are in product codes LCP (Assay, Glycosylated Hemoglobin) and JFY (Enzymatic Method, Creatinine). Its devices cite 7 predicates, 1 of them its own earlier devices. No 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 Axis-Shield Poc AS’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2008: 12011: 12014: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Axis-Shield Poc AS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LCPAssay, Glycosylated Hemoglobin2decisions
  • JFYEnzymatic Method, Creatinine1decision
  • CHHEnzymatic Esterase--Oxidase, Cholesterol1decision

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 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.

  • K110056Afinion AnalyzerAxis-Shield Poc AS · 20113cite it
  • K050574Afinion HbalcAxis-Shield Poc AS · 20053cite it
  • K072409Afinion Acr and Acr ControlAxis-Shield Poc AS · 20082cite it

What has FDA decided for it lately?

  • K132031Afinion Lipid Panel and Afinion Lipid Panel ControlAxis-Shield Poc AS · 2014
  • K110056Afinion AnalyzerAxis-Shield Poc AS · 2011
  • K072409Afinion Acr and Acr ControlAxis-Shield Poc AS · 2008
  • K050574Afinion HbalcAxis-Shield Poc AS · 2005

All 4 as Axis-Shield Poc AS →

Other applicant names beginning “Axis-Shield”

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

Axis-Shield Diagnostics, Ltd. 28Axis-Shield, Ltd. 3Axis Biochemicals, Asa 3Axis Orthopaedics 3Axis-Shield Biochemicals, Asa 2Axis Spine Technologies, Ltd. 2Axis-Shield Doc AS 1Axis Surgical Technologies, Inc. 1Axis 1Axis Health Care, LLC 1