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FDA 510(k) Application Details - K172868
Device Classification Name
System, Test, C-Reactive Protein
More FDA Info for this Device
510(K) Number
K172868
Device Name
System, Test, C-Reactive Protein
Applicant
The Binding Site Group Ltd.
8 Calthorpe Road, Edgbaston
Birmingham B15 1QT GB
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Contact
Kirsty Samuels
Other 510(k) Applications for this Contact
Regulation Number
866.5270
More FDA Info for this Regulation Number
Classification Product Code
DCN
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More FDA Info for this Product Code
Date Received
09/20/2017
Decision Date
02/28/2018
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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