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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 K220062
Device Name QIAstat-Dx Gastrointestinal Panel 2
Applicant
QIAGEN GmbH
QIAGEN Strasse 1
Hilden,  DE 40724
Applicant Contact Stephany Foster Spahr
Correspondent
QIAGEN Manchester Ltd
CityLabs 2.0, 200 Hathersage Road
Manchester,  GB M13 0BH
Correspondent Contact Selina Salthouse
Regulation Number866.3990
Classification Product Code
PCH  
Date Received01/10/2022
Decision Date 05/31/2024
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
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