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FDA 510(k) Application Details - K110934
Device Classification Name
Assay, Glycosylated Hemoglobin
More FDA Info for this Device
510(K) Number
K110934
Device Name
Assay, Glycosylated Hemoglobin
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
333 CONEY STREET
WALPOLE, MA 02032-1516 US
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Contact
Sandra D White
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Regulation Number
864.7470
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Classification Product Code
LCP
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More FDA Info for this Product Code
Date Received
04/04/2011
Decision Date
08/25/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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