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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name single (specified) analyte controls (assayed and unassayed)
510(k) Number K121895
Device Name ELECSYS HSV-2 IGG IMMUNOASSAY
Original Applicant
ROCHE DIAGNOSTICS
9115 hague road
indianapolis,  IN  46250 0416
Original Contact k. colleen adams
Regulation Number862.1660
Classification Product Code
JJX  
Subsequent Product Code
MYF  
Date Received06/29/2012
Decision Date 08/24/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
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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