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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lower Respiratory Microbial Nucleic Acid Detection System
510(k) Number K191967
Device Name Unyvero LRT BAL Application
Applicant
Curetis GmbH
Max-Eyth-Straße 42
Holzgerlingen,  DE 71088
Applicant Contact Karsten Mueller
Correspondent
Radcliffe Consulting, Inc.
231 Fairbanks St.
West Boylston,  MA  01583
Correspondent Contact Gail Radcliffe
Regulation Number866.3985
Classification Product Code
QBH  
Date Received07/23/2019
Decision Date 12/20/2019
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
Predetermined Change
Control Plan Authorized		 No
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