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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
Curetis GmbH
Max-Eyth-Straße 42
Holzgerlingen,  DE 71088
Applicant Contact Karsten Mueller
Radcliffe Consulting, Inc.
231 Fairbanks Street
West Boylston,  MA  01583
Correspondent Contact Gail Radcliffe
Regulation Number866.3985
Classification Product Code
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