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FDA 510(k) Application Details - K022690
Device Classification Name
System, Test, C-Reactive Protein
More FDA Info for this Device
510(K) Number
K022690
Device Name
System, Test, C-Reactive Protein
Applicant
HORIBA LTD.
34 BUNSEN DR.
IRVINE, CA 92618 US
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Contact
IAN GILES
Other 510(k) Applications for this Contact
Regulation Number
866.5270
More FDA Info for this Regulation Number
Classification Product Code
DCN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/13/2002
Decision Date
12/23/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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