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FDA 510(k) Application Details - K063608
Device Classification Name
Apolipoproteins
More FDA Info for this Device
510(K) Number
K063608
Device Name
Apolipoproteins
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
NEWARK,, DE 19714 US
Other 510(k) Applications for this Company
Contact
KATHLEEN DRAY-LYONS
Other 510(k) Applications for this Contact
Regulation Number
862.1475
More FDA Info for this Regulation Number
Classification Product Code
MSJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/04/2006
Decision Date
02/23/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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