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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioassay, Vitamin B12
510(k) Number K192064
Device Name LIAISON Vitamin B12
Applicant
DiaSorin, Inc.
1951 Northwestern Ave.
Stillwater,,  MN  55082 -0285
Applicant Contact John C. Walter
Correspondent
DiaSorin, Inc.
1951 Northwestern Ave., P.O. Box 285
Stillwater,  MN  55082 -0285
Correspondent Contact Mari Meyer
Regulation Number862.1810
Classification Product Code
CDD  
Date Received08/01/2019
Decision Date 10/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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