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FDA 510(k) Application Details - K101160
Device Classification Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
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510(K) Number
K101160
Device Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant
Roche Diagnostics
9115 HAGUE ROAD
INDIANAPOLIS, IN 46250-0416 US
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Contact
MICHELLE LEE NEFF
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Regulation Number
862.3250
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Classification Product Code
DIO
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More FDA Info for this Product Code
Date Received
04/26/2010
Decision Date
02/11/2011
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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