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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name test, epithelial ovarian tumor associated antigen (he4)
510(k) Number K112624
Device Name ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5
Original Applicant
Roche Diagnostics
9115 hague road
indianapolis,  IN  46250 -0416
Original Contact jane phillips
Regulation Number866.6010
Classification Product Code
OIU  
Subsequent Product Codes
JIT   JJX  
Date Received09/08/2011
Decision Date 09/10/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
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