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FDA 510(k) Application Details - K083412
Device Classification Name
System, Test, C-Reactive Protein
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510(K) Number
K083412
Device Name
System, Test, C-Reactive Protein
Applicant
MITSUBISHI KAGAKU IATRON
701 FIFTH AVENUE
FLOOR 42
SEATTLE, WA 98104 US
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Contact
HELEN LANDICHO
Other 510(k) Applications for this Contact
Regulation Number
866.5270
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Classification Product Code
DCN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/18/2008
Decision Date
03/09/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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