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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 immunosorbent assay, herpes simplex virus, hsv-1
510(k) Number K081685
Device Name LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG
Applicant
DIASORIN, INC.
1951 NORTHWESTERN AVE.
STILLWATER,  MN  55082 -0285
Applicant Contact CAROL A DEPOUW
Correspondent
DIASORIN, INC.
1951 NORTHWESTERN AVE.
STILLWATER,  MN  55082 -0285
Correspondent Contact CAROL A DEPOUW
Regulation Number866.3305
Classification Product Code
MXJ  
Subsequent Product Code
JJX  
Date Received06/17/2008
Decision Date 11/18/2008
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
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