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FDA 510(k) Application Details - K080469
Device Classification Name
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
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510(K) Number
K080469
Device Name
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Applicant
BIOMERIEUX, INC.
595 ANGLUM RD.
HAZELWOOD, MO 63042 US
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Contact
NIKITA S MAPP
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Regulation Number
866.6010
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Classification Product Code
LTK
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Date Received
02/21/2008
Decision Date
06/22/2009
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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