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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calprotectin, Fecal
510(k) Number K191718
Device Name Buhlmann fCAL turbo and CALEX Cap
Applicant
Buhlmann Laboratories AG
Baselstrasse 55
Schönenbuch,  CH 4124
Applicant Contact Laura Zurbrugg
Correspondent
QUARAS, LLC
2101 Camino Rey
Fullerton,  CA  92833
Correspondent Contact Roshana Ahmed
Regulation Number866.5180
Classification Product Code
NXO  
Date Received06/26/2019
Decision Date 09/24/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
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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