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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, Cocaine And Cocaine Metabolites
510(k) Number K023626
Device Name AML HAIRCHECK-DT (COCAINE)
Applicant
Quest Diagnostics, Inc.
4230 Burnham Ave.
Las Vegas,  NV  89119 -5410
Applicant Contact PATRICK CARPENTER
Correspondent
Quest Diagnostics, Inc.
4230 Burnham Ave.
Las Vegas,  NV  89119 -5410
Correspondent Contact PATRICK CARPENTER
Regulation Number862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DIF   DLJ  
Date Received10/29/2002
Decision Date 09/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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