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

    PHARMACIA MUMPS IGG ELISA

    K Number: K897006 · Decision Jul 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    220

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    Basic Information

    Device Name
    PHARMACIA MUMPS IGG ELISA
    K Number
    K897006
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3380
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Pharmacia Eni Diagnostics, Inc.
    Date Received
    December 18, 1989
    Decision Date
    July 26, 1990
    Product Code
    LJY
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LJY Enzyme Linked Immunoabsorbent Assay, Mumps Virus

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    Other Clearances by Pharmacia Eni Diagnostics, Inc.

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