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FDA 510(k) Application Details - K143534
Device Classification Name
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
More FDA Info for this Device
510(K) Number
K143534
Device Name
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Applicant
ROCHE PROFESSIONAL DIAGNOSTICS
9115 HAGUE ROAD
INDIANAPOLIS, IN 46250 US
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Contact
LINDA MCCAMMACK
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Regulation Number
866.6010
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Classification Product Code
LTK
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More FDA Info for this Product Code
Date Received
12/12/2014
Decision Date
08/06/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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