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FDA 510(k) Application Details - K053603
Device Classification Name
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
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510(K) Number
K053603
Device Name
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250 US
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Contact
THERESA M AMBROSE
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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
12/23/2005
Decision Date
02/09/2006
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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