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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
510(k) Number K242353
Device Name QIAstat-Dx Respiratory Panel Mini
Applicant
Qiagen GmbH
Qiagen Strasse 1
Hilden,  DE 40724
Applicant Contact Autumn Collasius
Correspondent
Qiagen
19300 Germantown Road
Germantown,  MD  20874
Correspondent Contact Melissa Mahall
Regulation Number866.3981
Classification Product Code
QOF  
Date Received08/08/2024
Decision Date 10/25/2024
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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