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FDA 510(k) Application Details - K946215
Device Classification Name
System, Test, Anticardiolipin Immunological
More FDA Info for this Device
510(K) Number
K946215
Device Name
System, Test, Anticardiolipin Immunological
Applicant
HOGAN & HARTSON
COLUMBIA SQUARE
555 THIRTEENTH STREET N.W.
WASHINGTON, DC 20004 US
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Contact
EDWARD C WILSON
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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
12/21/1994
Decision Date
01/24/1996
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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