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

    QUIKSTRIP ONESTEP MARIJUANA (THC) TEST

    K Number: K963654 · Decision Feb 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    149
    Applicant Total
    26
    Review Days
    169

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    Basic Information

    Device Name
    QUIKSTRIP ONESTEP MARIJUANA (THC) TEST
    K Number
    K963654
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3870
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Syntron Bioresearch, Inc.
    Date Received
    September 12, 1996
    Decision Date
    February 28, 1997
    Product Code
    LDJ
    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
    LDJ Enzyme Immunoassay, Cannabinoids

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    Other Clearances by Syntron Bioresearch, Inc.

    K Number Device Name
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    K992748 DRUGCHECK X MULTIDRUG SCREENING DEVICE
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    K990325 QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE
    K983113 BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT
    K981292 QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST
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