FDA 510(k) Application Details - K080467

Device Classification Name Enzyme Immunoassay, Cannabinoids

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510(K) Number K080467
Device Name Enzyme Immunoassay, Cannabinoids
Applicant APPLIED DNA TECHNOLOGIES, INC.
26251 VERONA PLACE
MISSION VIEJO, CA 92692 US
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Contact FENG YU-LEE
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Regulation Number 862.3870

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Classification Product Code LDJ
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Date Received 02/21/2008
Decision Date 11/25/2008
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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