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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name respiratory virus panel nucleic acid assay system
510(k) Number K183597
Device Name QIAstat-Dx Respiratory Panel
Applicant
QIAGEN GmbH
Qiagen Strasse 1
Hilden,  DE 40724
Applicant Contact Lindsey Howard
Correspondent
QIAGEN
19300 Germantown Road
Germantown,  MD  20874
Correspondent Contact Melissa Mahall
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
OEM   OEP   OOI   OOU   OQW  
OTG   OZX   OZY   OZZ  
Date Received12/21/2018
Decision Date 05/18/2019
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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