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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
510(k) Number K040290
Device Name DIASORIN LIAISON CMV IGM/IGG
Applicant
Diasorin S.P.A
1951 Northwestern Ave., P.O. Box 285
Stillwater,  MN  55082 -0285
Applicant Contact DAVID M IKEDA
Correspondent
Diasorin S.P.A
1951 Northwestern Ave., P.O. Box 285
Stillwater,  MN  55082 -0285
Correspondent Contact DAVID M IKEDA
Regulation Number866.3175
Classification Product Code
LFZ  
Date Received02/06/2004
Decision Date 06/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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