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FDA 510(k) Application Details - K980240
Device Classification Name
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
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510(K) Number
K980240
Device Name
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Applicant
BOEHRINGER MANNHEIM CORP.
4300 HACIENDA DR.
PLEASANTON, CA 94588-2722 US
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Contact
JODY J SAVAGE
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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
01/23/1998
Decision Date
03/25/1998
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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