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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, Methadone
510(k) Number K160793
Device Name First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)
Applicant
W.H.P.M., Inc.
5358 Irwindale Ave.
Irwindale,  CA  91706
Applicant Contact John Wan
Correspondent
Lsi Consulting
504 E. Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3620
Classification Product Code
DJR  
Subsequent Product Codes
LAF   LFG  
Date Received03/23/2016
Decision Date 08/17/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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