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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 K233100
Device Name QIAstat-Dx® Respiratory Panel Plus
Applicant
QIAGEN GmbH
Qiagen Strasse 1
Hiden,  DE 40724
Applicant Contact Autumn Collasius
Correspondent
Qiagen
19300 Germantown Rd.
Gernmantown,  MD  20874
Correspondent Contact Melissa Mahall
Regulation Number866.3981
Classification Product Code
QOF  
Date Received09/26/2023
Decision Date 05/10/2024
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
Recalls CDRH Recalls
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