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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, Toxoplasma Gondii
510(k) Number K132234
Device Name LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II
Applicant
DiaSorin, Inc.
1951 Northwestern Ave.
P.O. Box 285
Stillwater,  MN  55082
Applicant Contact JOHN ESKDALE
Correspondent
DiaSorin, Inc.
1951 Northwestern Ave.
P.O. Box 285
Stillwater,  MN  55082
Correspondent Contact JOHN ESKDALE
Regulation Number866.3780
Classification Product Code
LGD  
Date Received07/18/2013
Decision Date 08/28/2013
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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