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

    IMMUSTAPH LATEX AGGLUTINATION KIT

    K Number: K842709 · Decision Aug 3, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    22

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    Basic Information

    Device Name
    IMMUSTAPH LATEX AGGLUTINATION KIT
    K Number
    K842709
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3700
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Immucell Corp.
    Date Received
    July 12, 1984
    Decision Date
    August 3, 1984
    Product Code
    LHJ
    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
    LHJ Staphylococcus Aureus Protein A Insoluble

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LHJ), ordered by most recent decision date.

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