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FDA 510(k) Application Details - K990431
Device Classification Name
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
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510(K) Number
K990431
Device Name
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Applicant
TOSOH MEDICS, INC.
347 OYSTER POINT BLVD.,
SUITE 201
SAN FRANCISCO, CA 94080 US
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Contact
JUDITH E LOEBEL
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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
02/11/1999
Decision Date
06/03/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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