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FDA 510(k) Application Details - K992311
Device Classification Name
C-Reactive Protein, Antigen, Antiserum, And Control
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510(K) Number
K992311
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
COLIN GETTY
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Regulation Number
866.5270
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Classification Product Code
DCK
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Date Received
07/09/1999
Decision Date
09/13/1999
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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