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FDA 510(k) Application Details - K964098
Device Classification Name
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
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510(K) Number
K964098
Device Name
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Applicant
BAYER CORP.
511 BENEDICT AVE.
TARRYTOWN, NY 10591-5097 US
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Contact
GABRIEL J MURACA, JR.
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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
10/11/1996
Decision Date
10/31/1997
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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