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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document Numberk150162
Test Name Zero Chaos, zerochaos Drug Test Cup  
Consumer Information Phone Number1(877)937-6242
Test TypeMorphine
Effective Date07/02/2019
Device Classification Name Gas Chromatography, Methamphetamine
510(k) Number K150162
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
W.H.P.M., Inc.
5358 Irwindale Ave.
Irwindale,  CA  91706
Correspondent Contact John Wan
Regulation Number862.3610
Classification Product Code
LAF  
Subsequent Product Codes
DJG   JXM  
Date Received01/26/2015
Decision Date 02/26/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
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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