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Data / Medical devices / Belgium / Lacar MDX Technologies

Lacar MDX Technologies: FDA-registered device maker in Liege, Belgium, 1 510(k) clearance

Lacar MDX Technologies is registered with the FDA (registration 3042250641) in Liege, Belgium. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 3, 2017. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
3042250641
Address
Rue des Chasseurs Ardennais 10, Liege, Belgium, 4031
Owner or operator
LaCAR MDx Technologies (10094131)
Roles
Complaint file establishment, Manufacturer, Specification developer
First device listed
November 17, 2025
Registered through
2027
Brand names listed
Analyte Specific Reagent, General Purpose Reagent, SEEKER, SEEKER Instrument

Devices it lists

DeviceProduct codeClassRoleSource
Alpha-D-Galactosidase A (Gla) Newborn Screening Test SystemPQW2Complaint file establishment, Manufactureraccessdata.fda.gov
Alpha-D-Glucosidase (Gaa) Newborn Screening Test SystemPQU2Complaint file establishment, Manufactureraccessdata.fda.gov
Alpha-L-Iduronidase (Idua) Newborn Screening Test SystemPQT2Complaint file establishment, Manufactureraccessdata.fda.gov
Fluorometer, For Clinical UseKHO1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
General Purpose ReagentPPM1Complaint file establishment, Manufactureraccessdata.fda.gov
Reagents, Specific, AnalyteMVU1Complaint file establishment, Manufactureraccessdata.fda.gov
ß-Glucocerebrosidase (Gba) Newborn Screening Test SystemPQV2Complaint file establishment, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 3, 2017DEN150035SEEKER SystemPQWUnknownBaebies, Inc.accessdata.fda.gov

Compare with other makers

Updated February 3, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.