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

    BACTIGEN S. PNEUMONIAE

    K Number: K831887 · Decision Sep 26, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    68
    Review Days
    105

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    Basic Information

    Device Name
    BACTIGEN S. PNEUMONIAE
    K Number
    K831887
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3740
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Armkel, LLC
    Date Received
    June 13, 1983
    Decision Date
    September 26, 1983
    Product Code
    GWC
    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
    GWC Antisera, All Types, Streptococcus Pneumoniae

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