FDA applicant

Cambridge Diagnostics Ireland, Ltd.

Galway, IE4 decisions1996–20010 recalls

FDA records 4 decisions for Cambridge Diagnostics Ireland, Ltd. (Galway, IE) from 1996 to 2001: 4 510(k) clearances. Most are in product codes LCX (Kit, Test, Pregnancy, Hcg, Over The Counter) and LSR (Reagent, Borrelia Serological Reagent). Its devices cite 1 predicate, 0 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 Cambridge Diagnostics Ireland, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cambridge Diagnostics Ireland, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cambridge Diagnostics Ireland, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Cambridge”

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

Cambridge Heart, Inc. 17 Cambridge Medical Technology 14 Cambridge Instruments, Inc. 13 Cambridge Medical Instruments, Inc. 8 Cambridge Bioscience Corp. 5 Cambridge Nuclear Corp. 5 Cambridge Chemical Products, Inc. 4 Cambridge Life Sciences Plc. 4 Cambridge Sensors Limited 3 Cambridge Biotech Corp. 3 Cambridge Scientific 2 Cambridge Technologies, Inc. 2

Cambridge Diagnostics Ireland, Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Cambridge”