510(k) Report

FDA applicant

Europa Scientific, Ltd.

Concord, MA1 decision1997–19970 recalls

FDA records 1 decision for Europa Scientific, Ltd. (Concord, MA) in 1997: 1 510(k) clearance. All are in product code DOP (Mass Spectrometer, Clinical Use). 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 Europa Scientific, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Europa Scientific, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Europa Scientific, Ltd. 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?

  • DOPMass Spectrometer, Clinical Use1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K974322Abca-NT Gas Isotope Ratio Mass Spectrometer SystemEuropa Scientific, Ltd. · 19972cite it

What has FDA decided for it lately?

  • K974322Abca-NT Gas Isotope Ratio Mass Spectrometer SystemEuropa Scientific, Ltd. · 1997

The one decision as Europa Scientific, Ltd. →

Other applicant names beginning “Europa”

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

Europa/Encore Eyewear 1Europa Continental, Inc. 1