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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 K232057
Device Name BÜHLMANN fCAL® turbo and CALEX® Cap
Applicant
BÜHLMANN Laboratories AG
Baselstrasse 55
Schönenbuch,  CH 4124
Applicant Contact Laura Zurbrugg
Correspondent
Quaras, LLC
2101 Camino Rey
Fullerton,  CA  92833
Correspondent Contact Roshana Ahmed, M.A., RAC
Regulation Number866.5180
Classification Product Code
NXO  
Date Received07/11/2023
Decision Date 02/06/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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