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FDA 510(k) Application Details - K014293
Device Classification Name
Ferritin, Antigen, Antiserum, Control
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510(K) Number
K014293
Device Name
Ferritin, Antigen, Antiserum, 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
866.5340
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Classification Product Code
DBF
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Date Received
12/28/2001
Decision Date
02/19/2002
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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