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FDA 510(k) Application Details - K011962
Device Classification Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
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510(K) Number
K011962
Device Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant
ADVANTAGE DIAGNOSTICS CORP.
4 HOLYROOD ST.
CHARD, SOMERSET TA 20 2AH GB
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Contact
JANIS FREESTONE
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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
06/22/2001
Decision Date
08/09/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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