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FDA 510(k) Application Details - K192118
Device Classification Name
C-Reactive Protein, Antigen, Antiserum, And Control
More FDA Info for this Device
510(K) Number
K192118
Device Name
C-Reactive Protein, Antigen, Antiserum, And Control
Applicant
Sentinel CH, Spa
Via Robert Koch, 2
Milano 20152 IT
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Contact
Patricia Dupe
Other 510(k) Applications for this Contact
Regulation Number
866.5270
More FDA Info for this Regulation Number
Classification Product Code
DCK
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More FDA Info for this Product Code
Date Received
08/06/2019
Decision Date
11/08/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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