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Data / Medical devices / Switzerland / Tecan Trading AG

Tecan Trading AG: FDA-registered device maker in Maennedorf Zurich, Switzerland, 4 510(k) clearances

Tecan Trading AG is registered with the FDA (registration 3003559191) in Maennedorf Zurich, Switzerland. It lists 22 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 25, 2015. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3003559191
Address
103 Seestrasse, Maennedorf Zurich, Switzerland, 8708
Owner or operator
Tecan Group AG (9050992)
Roles
Complaint file establishment
First device listed
November 6, 2001
Registered through
2026
Brand names listed
17-OH-Progesterone ELISA (30223011), 17beta-Estradiol Saliva Luminescence Immunoassay, 96PW, AUTOREADER IV, AVENIO Edge System, Acetylcholine Receptor Autoantibodies (ARAb) RRA, AcfS Detection Robot, AcfS L&D Equipment Installation Bundle and more

Devices it lists

DeviceProduct codeClassRoleSource
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Complaint file establishmentaccessdata.fda.gov
Analyzer, Chemistry, Micro, For Clinical UseJJF1Complaint file establishmentaccessdata.fda.gov
Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-BlockingNST2Complaint file establishmentaccessdata.fda.gov
Calculator/Data Processing Module, For Clinical UseJQP1Complaint file establishmentaccessdata.fda.gov
Calibrator, SecondaryJIT2Complaint file establishmentaccessdata.fda.gov
Centrifuges (Micro, Ultra, Refrigerated) For Clinical UseJQC1Complaint file establishmentaccessdata.fda.gov
Colorimeter, Photometer, Spectrophotometer For Clinical UseJJQ1Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, Cortisol, SalivaryNHG2Complaint file establishmentaccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Complaint file establishmentaccessdata.fda.gov
Fluorometer, For Clinical UseKHO1Complaint file establishmentaccessdata.fda.gov
General Purpose ReagentPPM1Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, 17-HydroxyprogesteroneJLX1Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)JKC1Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, EstradiolCHP1Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, ProgesteroneJLS1Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, Testosterones And DihydrotestosteroneCDZ1Complaint file establishmentaccessdata.fda.gov
Research Use Only/Clinical Chemistry DevicesOTVNComplaint file establishmentaccessdata.fda.gov
Research Use Only/Immunology DevicesOTRNComplaint file establishmentaccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Complaint file establishmentaccessdata.fda.gov
Slide Stainer, AutomatedKPA1Complaint file establishmentaccessdata.fda.gov
Station, Pipetting And Diluting, For Clinical UseJQW1Complaint file establishmentaccessdata.fda.gov
Test, Equipment, Automated Bloodborne PathogenMZANComplaint file establishmentaccessdata.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
November 25, 2015K150528Cortisol Saliva Luminescence ImmunoassayNHGSubstantially EquivalentIbl International GmbHaccessdata.fda.gov
November 18, 2005K051144ACETYLCHOLINE RECEPTOR AB (ARAB)RRANSTSubstantially EquivalentIbl-Hamburg GmbHaccessdata.fda.gov
July 22, 2004K040923LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVAJLSSubstantially EquivalentIbl GmbHaccessdata.fda.gov
February 27, 2004K033786LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVAJITSubstantially EquivalentIbl GmbHaccessdata.fda.gov

Compare with other makers

Updated November 25, 2015. 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.