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OTC - Over The Counter
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Document NumberK152551
Test Name Origin Diagnostics Origin Instant Drug Test (Morphine)  
Manufacturer NameW.H.P.M., INC.
Consumer Information Phone Number1(800)440-6695
Test TypeMorphine
Effective Date01/06/2020
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
504E 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
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