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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, rubella
510(k) Number K122397
Device Name LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM
Original Applicant
DIASORIN, INC.
1951 northwestern ave.
stillwater,  MN  55082 -0285
Original Contact carol a depouw
Regulation Number866.3510
Classification Product Code
LFX  
Subsequent Product Code
JJX  
Date Received08/07/2012
Decision Date 09/06/2012
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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