FDA 510(k) Application Details - K020828

Device Classification Name Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)

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510(K) Number K020828
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 KENNETH T EDDS
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Regulation Number 866.6010

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Classification Product Code LTK
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Date Received 03/14/2002
Decision Date 07/24/2002
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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