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FDA 510(k) Application Details - K952521
Device Classification Name
System, Test, Anticardiolipin Immunological
More FDA Info for this Device
510(K) Number
K952521
Device Name
System, Test, Anticardiolipin Immunological
Applicant
IMMUNO PROBE, INC.
COLUMBIA SQUARE
555 THIRTEENTH STREET NW
WASHINGTON, DC 20004-1109 US
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Contact
EDWARD C WILSON, JR.
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Regulation Number
866.5660
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Classification Product Code
MID
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More FDA Info for this Product Code
Date Received
06/01/1995
Decision Date
02/09/1996
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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