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

    TECHNICON FAST-LC SYS. ANTICONVU DRUGS

    K Number: K791979 · Decision Nov 13, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    157
    Review Days
    49

    Basic Information

    Device Name
    TECHNICON FAST-LC SYS. ANTICONVU DRUGS
    K Number
    K791979
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3350
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    TECHNICON INSTRUMENTS CORP.
    Date Received
    September 25, 1979
    Decision Date
    November 13, 1979
    Product Code
    DPE
    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
    DPE Thin Layer Chromatography, Diphenylhydantoin

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