BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DETECTABUSE(TM)

    K Number: K925586 · Decision Dec 28, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    201
    Applicant Total
    5
    Review Days
    54

    Basic Information

    Device Name
    DETECTABUSE(TM)
    K Number
    K925586
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BIOCHEMICAL DIAGNOSTIC, INC.
    Date Received
    November 4, 1992
    Decision Date
    December 28, 1992
    Product Code
    DIF
    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
    DIF Drug Mixture Control Materials

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    Other Clearances by BIOCHEMICAL DIAGNOSTIC, INC.

    K Number Device Name
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    K904181 ANTI-GBM ANTIBODIES QUANTITATIVE KIT
    K841831 CANNU-SKREEN-PRELIMINARY