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

    BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST

    K Number: K971841 · Decision Jun 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    149
    Applicant Total
    6
    Review Days
    37

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    Basic Information

    Device Name
    BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST
    K Number
    K971841
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3870
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bionike Laboratories, Inc.
    Date Received
    May 19, 1997
    Decision Date
    June 25, 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 Bionike Laboratories, Inc.

    K Number Device Name
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    K960992 BIONIKE A/Q PREGNANCY TEST
    K954901 BIONIKE A/Q PREGNANCY TEST