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FDA 510(k) Application Details - K061802
Device Classification Name
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
More FDA Info for this Device
510(K) Number
K061802
Device Name
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
NEWARK, DE 19714-6101 US
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Contact
KATHLEEN DRAY-LYONS
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Regulation Number
866.5270
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Classification Product Code
NQD
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More FDA Info for this Product Code
Date Received
06/27/2006
Decision Date
09/11/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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