510(k) Report

FDA applicant

Canterbury Health Laboratories

Christchurch, Canterbury, NZ1 decision2001–20010 recalls

FDA records 1 decision for Canterbury Health Laboratories (Christchurch, Canterbury, NZ) in 2001: 1 510(k) clearance. All are in product code JCM (Control, Hemoglobin, Abnormal). 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, hematology panel, where it files most

How often FDA has decided Canterbury Health Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Canterbury Health Laboratories since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Canterbury Health Laboratories 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?

  • JCMControl, Hemoglobin, Abnormal1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K011389Hemoglobin F & A2 Control (Beta-Thalassaemia Control)Canterbury Health Laboratories · 20011cites it

What has FDA decided for it lately?

  • K011389Hemoglobin F & A2 Control (Beta-Thalassaemia Control)Canterbury Health Laboratories · 2001

The one decision as Canterbury Health Laboratories →

Other applicant names beginning “Canterbury”

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

Canterbury Scientific, Ltd. 3