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FDA 510(k) Application Details - K040241
Device Classification Name
C-Reactive Protein, Antigen, Antiserum, And Control
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510(K) Number
K040241
Device Name
C-Reactive Protein, Antigen, Antiserum, And Control
Applicant
GENZYME CORP.
ONE KENDALL SQUARE
CAMBRIDGE, MA 02139 US
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Contact
FRED D LASKY
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Regulation Number
866.5270
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Classification Product Code
DCK
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More FDA Info for this Product Code
Date Received
02/03/2004
Decision Date
06/25/2004
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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