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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 K182698
Device Name LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device
Applicant
DiaSorin, Inc.
1951 Northwestern Ave.
Stillwater,  MN  55082
Applicant Contact John C. Walter
Correspondent
DiaSorin, Inc.
1951 Northwestern Ave.
Stillwater,  MN  55082
Correspondent Contact Sandra Zimniewicz
Regulation Number866.5180
Classification Product Code
NXO  
Subsequent Product Code
JJX  
Date Received09/27/2018
Decision Date 12/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT03143517
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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