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

    MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL

    K Number: K881259 · Decision Oct 12, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    203

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    Basic Information

    Device Name
    MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL
    K Number
    K881259
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Triton Biosciences, Inc.
    Date Received
    March 23, 1988
    Decision Date
    October 12, 1988
    Product Code
    LYE
    Advisory Committee
    Immunology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LYE Cytokeratins

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