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FDA 510(k) Application Details - K040257
Device Classification Name
Enzyme Immunoassay, Cannabinoids
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510(K) Number
K040257
Device Name
Enzyme Immunoassay, Cannabinoids
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
862.3870
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Classification Product Code
LDJ
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Date Received
02/04/2004
Decision Date
06/14/2004
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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