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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.
p.o. box 285
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 - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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