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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 Immunoabsorption Assay, Treponema Pallidum
510(k) Number K061247
FOIA Releasable 510(k) K061247
Device Name DIASORIN LIAISON TREPONEMA ASSAY
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
LIP  
Date Received05/03/2006
Decision Date 07/31/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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