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FDA 510(k) Application Details - K023828
Device Classification Name
C-Reactive Protein, Antigen, Antiserum, And Control
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510(K) Number
K023828
Device Name
C-Reactive Protein, Antigen, Antiserum, And Control
Applicant
KAMIYA BIOMEDICAL CO.
910 INDUSTRY DR.
SEATTLE, WA 98188-3412 US
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Contact
BRIAN SCHLIESMAN
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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
11/18/2002
Decision Date
02/04/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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