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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
510(k) Number K242256
Device Name QIAstat-Dx Meningitis/Encephalitis (ME) Panel
Applicant
QIAGEN GmbH
QIAGEN Strasse 1
Hilden,  DE 40724
Applicant Contact Autumn Collasius
Correspondent
STAT-Dx Life, S.L. (A QIAGEN Company)
Carrer Baldiri Reixac, 4
Barcelona,  ES 08028
Correspondent Contact Sonia Pablo Pablo
Regulation Number866.3970
Classification Product Code
PLO  
Date Received07/31/2024
Decision Date 10/29/2024
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
Predetermined Change
Control Plan Authorized		 No
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