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FDA 510(k) Application Details - K083386
Device Classification Name
Azo Dye, Calcium
More FDA Info for this Device
510(K) Number
K083386
Device Name
Azo Dye, Calcium
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict Avenue
Tarrytown, NY 10591 US
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Contact
CAROL BIANCA
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Regulation Number
862.1145
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Classification Product Code
CJY
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More FDA Info for this Product Code
Date Received
11/17/2008
Decision Date
04/02/2009
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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