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FDA 510(k) Application Details - K100289
Device Classification Name
Enzymatic, Carbon-Dioxide
More FDA Info for this Device
510(K) Number
K100289
Device Name
Enzymatic, Carbon-Dioxide
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
333 Coney Street
Walpole, MA 02032 US
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Contact
Sandra D White
Other 510(k) Applications for this Contact
Regulation Number
862.1160
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Classification Product Code
KHS
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More FDA Info for this Product Code
Date Received
02/02/2010
Decision Date
05/10/2010
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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