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

    LD-1(IMMUNO) SEPARATION SET

    K Number: K851521 · Decision May 10, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    7
    Applicant Total
    20
    Review Days
    25

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    Basic Information

    Device Name
    LD-1(IMMUNO) SEPARATION SET
    K Number
    K851521
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1445
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Seragen Diagnostics, Inc.
    Date Received
    April 15, 1985
    Decision Date
    May 10, 1985
    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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