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FDA 510(k) Application Details - K030234
Device Classification Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
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510(K) Number
K030234
Device Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant
COZART BIOSCIENCE LTD.
45 MILTON PARK
ABINGDON, OXON OX14 4RU GB
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Contact
ROBERTO LIDDI
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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
01/23/2003
Decision Date
04/28/2003
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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