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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 K142353
Device Name First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test
Applicant
W.H.P.M., Inc.
5358 Irwindale Ave.
Irwindale,  CA  91706
Applicant Contact John Wan
Correspondent
LSI International, Inc.
504 E. Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DKZ   LDJ  
Date Received08/21/2014
Decision Date 10/07/2014
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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