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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
Hiden,  DE 40724
Applicant Contact Autumn Collasius
Correspondent
Qiagen
19300 Germantown Rd.
Gernmantown,  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
Predetermined Change
Control Plan Authorized		 No
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