BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test

    K Number: K142353 · Decision Oct 7, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    144
    Applicant Total
    14
    Review Days
    47

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    Basic Information

    Device Name
    First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test
    K Number
    K142353
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3250
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W.H.P.M., Inc.
    Date Received
    August 21, 2014
    Decision Date
    October 7, 2014
    Product Code
    DIO
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

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    Other Clearances by W.H.P.M., Inc.

    K Number Device Name
    K200754 Hemosure Accu-Reader A100
    K210327 First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup
    K171695 First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana
    K160793 First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)
    K152551 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.
    K151441 First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
    K150162 First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
    K052197 FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST
    K051841 WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST
    K041202 HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST
    Search all 14 clearances from W.H.P.M., Inc. →