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FDA 510(k) Application Details - K211058
Device Classification Name
Lipoprotein, Low-Density, Antigen, Antiserum, Control
More FDA Info for this Device
510(K) Number
K211058
Device Name
Lipoprotein, Low-Density, Antigen, Antiserum, Control
Applicant
Sentinel CH. SpA
Via Robert Koch 2
Milan 20152 IT
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Contact
Patricia DupΘ
Other 510(k) Applications for this Contact
Regulation Number
866.5600
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Classification Product Code
DFC
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More FDA Info for this Product Code
Date Received
04/09/2021
Decision Date
12/22/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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