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

    LDH ISOENZYME COLUMN REAGENT SET

    K Number: K772356 · Decision Jan 24, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    7
    Applicant Total
    13
    Review Days
    28

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    Basic Information

    Device Name
    LDH ISOENZYME COLUMN REAGENT SET
    K Number
    K772356
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1445
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Worthington Biochemical Corp.
    Date Received
    December 27, 1977
    Decision Date
    January 24, 1978
    Product Code
    CEX
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CEX Chromatographic Separation, Lactate Dehydrogenase Isoenzymes

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