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FDA 510(k) Application Details - K110169
Device Classification Name
Calibrator, Secondary
More FDA Info for this Device
510(K) Number
K110169
Device Name
Calibrator, Secondary
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
500 GBC DRIVE
MS 514
NEWARK, DE 19702 US
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Contact
KATHLEEN ANN DRAY-LYONS
Other 510(k) Applications for this Contact
Regulation Number
862.1150
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Classification Product Code
JIT
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More FDA Info for this Product Code
Date Received
01/20/2011
Decision Date
04/07/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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