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FDA 510(k) Application Details - K093939
Device Classification Name
Colorimetry, Salicylate
More FDA Info for this Device
510(K) Number
K093939
Device Name
Colorimetry, Salicylate
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict Avenue
Tarrytown, NY 10591 US
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Contact
KIRA GORDON
Other 510(k) Applications for this Contact
Regulation Number
862.3830
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Classification Product Code
DKJ
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More FDA Info for this Product Code
Date Received
12/22/2009
Decision Date
05/19/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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