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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
510(k) Number K243813
Device Name QIAstat-Dx GI Panel 2 Mini B&V
Applicant
Qiagen GmbH
Qiagen Strasse 1
Hilden,  DE 40724
Applicant Contact Autumn Collasius
Correspondent
Qiagen
19300 Germantown Road
Germantown,  MD  20874
Correspondent Contact Colleen Adams
Regulation Number866.3990
Classification Product Code
PCH  
Date Received12/11/2024
Decision Date 01/08/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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