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FDA 510(k) Application Details - K983695
Device Classification Name
System, Test, Anticardiolipin Immunological
More FDA Info for this Device
510(K) Number
K983695
Device Name
System, Test, Anticardiolipin Immunological
Applicant
THE BINDING SITE, LTD.
EAST TOWER, SUITE 600
2425 WEST OLYMPIC BOULEVARD
SANTA MONICA, CA 90404 US
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Contact
JAY H GELLER
Other 510(k) Applications for this Contact
Regulation Number
866.5660
More FDA Info for this Regulation Number
Classification Product Code
MID
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More FDA Info for this Product Code
Date Received
10/21/1998
Decision Date
02/05/1999
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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