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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Human Chorionic Gonadotropin
510(k) Number K131037
Device Name LIAISON XL HCG
Applicant
DiaSorin, Inc.
1951 Northwestern Ave.
Stillwater,,  MN  55082 -0285
Applicant Contact Mari Meyer
Correspondent
DiaSorin, Inc.
1951 Northwestern Ave.
Stillwater,,  MN  55082 -0285
Correspondent Contact Mari Meyer
Regulation Number862.1155
Classification Product Code
DHA  
Date Received04/15/2013
Decision Date 09/06/2013
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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