FDA 510(k) Application Details - K170293

Device Classification Name Enzyme Immunoassay, Cocaine And Cocaine Metabolites

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510(K) Number K170293
Device Name Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant SIEMENS HEALTHCARE DIAGNOSTICS INC.
P.O. BOX 6101
M/S 514
NEWARK, DE 19714-6101 US
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Contact ALAN HALEY
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Regulation Number 862.3250

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Classification Product Code DIO
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Date Received 01/31/2017
Decision Date 10/25/2017
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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