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FDA 510(k) Application Details - K212559
Device Classification Name
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
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510(K) Number
K212559
Device Name
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
Applicant
Siemens Healthcare Diagnostics Products GmbH
Emil-von-Behring Str. 76
Marburg 35041 DE
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Contact
Martina Pfeiff
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Regulation Number
866.5270
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Classification Product Code
NQD
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More FDA Info for this Product Code
Date Received
08/13/2021
Decision Date
12/16/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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