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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
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