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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK152551
Test Name Zero Chaos, zerochaos Butalbital Drug Test Cup  
Manufacturer NameW.H.P.M., Inc.
Consumer Information Phone Number1(877)937-6242
Test TypeBarbiturates
Effective Date07/02/2019
Device Classification Name Enzyme Immunoassay, Opiates
510(k) Number K152551
Device Name First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test.
Applicant
W.H.P.M., Inc.
5358 Irwindale Ave.
Irwindale,  CA  91706
Applicant Contact JOHN WAN
Correspondent
Lsi
504 E. Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact JOE SHIA
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Code
DIS  
Date Received09/08/2015
Decision Date 11/09/2015
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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