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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name multi-target respiratory specimen nucleic acid test including sars-cov-2 and other microbial agents
510(k) Number K233100
Device Name QIAstat-Dx® Respiratory Panel Plus
Qiagen Strasse 1
Hilden,  DE 40724
Applicant Contact Autumn Collasius
19300 Germantown Road
Germantown,  MD  20874
Correspondent Contact Melissa Mahall
Regulation Number866.3981
Classification Product Code
Date Received09/26/2023
Decision Date 05/10/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No