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FDA 510(k) Application Details - K071455
Device Classification Name
Cyclosporine
More FDA Info for this Device
510(K) Number
K071455
Device Name
Cyclosporine
Applicant
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
511 benedict Avenue
Tarrytown, NY 10591 US
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Contact
MARY SEEGER
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Regulation Number
862.1235
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Classification Product Code
MKW
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More FDA Info for this Product Code
Date Received
05/25/2007
Decision Date
09/11/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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