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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Borrelia Serological Reagent
510(k) Number K062473
Device Name LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871
Applicant
DiaSorin, Inc.
1951 Northwestern Ave.
P.O. Box 285
Stillwater,  MN  55082
Applicant Contact CAROL A DEPOUW
Correspondent
DiaSorin, Inc.
1951 Northwestern Ave.
P.O. Box 285
Stillwater,  MN  55082
Correspondent Contact CAROL A DEPOUW
Regulation Number866.3830
Classification Product Code
LSR  
Date Received08/24/2006
Decision Date 04/12/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
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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