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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzyme immunoassay, opiates
510(k) Number K042725
Device Name QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES)
Applicant
QUEST DIAGNOSTICS, INC.
4230 BURNHAM AVE.
LAS VEGAS,  NV  89119 -5410
Applicant Contact JAMES A BOURLAND
Correspondent
QUEST DIAGNOSTICS, INC.
4230 BURNHAM AVE.
LAS VEGAS,  NV  89119 -5410
Correspondent Contact JAMES A BOURLAND
Regulation Number862.3650
Classification Product Code
DJG  
Date Received10/01/2004
Decision Date 07/06/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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