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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK142353
Test Name Origin Diagnostics, Origin Instant Dip Drug Test  
Manufacturer NameW.H.P.M., Inc.
Consumer Information Phone Number(800)440-6695
Test TypeCannabinoids (THC)
Effective Date01/19/2022
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 EAST 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
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