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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Epstein-Barr Virus, Other
510(k) Number K060204
Device Name LIAISON EA IGG
Applicant
DiaSorin, Inc.
1951 Northwestern Ave.
P.O. Box 285
Stillwater,  MN  55082
Applicant Contact DAVID M IKEDA
Correspondent
Tuv America, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Regulation Number866.3235
Classification Product Code
LSE  
Date Received01/26/2006
Decision Date 10/18/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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