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FDA 510(k) Application Details - K090900
Device Classification Name
Calibrators, Drug Mixture
More FDA Info for this Device
510(K) Number
K090900
Device Name
Calibrators, Drug Mixture
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict Avenue
Tarrytown, NY 10591 US
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Contact
KIRA GORDON
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Regulation Number
862.3200
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Classification Product Code
DKB
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More FDA Info for this Product Code
Date Received
04/01/2009
Decision Date
06/01/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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