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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-2
510(k) Number K081687
Device Name LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 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
MYF  
Subsequent Product Code
JJX  
Date Received06/17/2008
Decision Date 11/10/2008
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
Recalls CDRH Recalls
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