FDA 510(k) Application Details - K972162

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

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510(K) Number K972162
Device Name Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Applicant BOEHRINGER MANNHEIM CORP.
9112 HAGUE RD.
INDIANAPOLIS, IN 46256 US
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Contact LEEANN CHAMBERS
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Regulation Number 866.6010

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Classification Product Code LTK
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Date Received 06/09/1997
Decision Date 03/18/1998
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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