FDA 510(k) Application Details - K023626

Device Classification Name Enzyme Immunoassay, Cocaine And Cocaine Metabolites

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510(K) Number K023626
Device Name Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant QUEST DIAGNOSTICS, INC.
4230 BURNHAM AVE.
LAS VEGAS, NV 89119-5410 US
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Contact PATRICK CARPENTER
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Regulation Number 862.3250

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Classification Product Code DIO
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Date Received 10/29/2002
Decision Date 09/29/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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