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

    AGGLUTINATING SERUM W135

    K Number: K771562 · Decision Aug 25, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    15
    Applicant Total
    17
    Review Days
    10

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    Basic Information

    Device Name
    AGGLUTINATING SERUM W135
    K Number
    K771562
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Burroughs Wellcome Co.
    Date Received
    August 15, 1977
    Decision Date
    August 25, 1977
    Product Code
    GTJ
    Advisory Committee
    Microbiology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GTJ Antisera, All Groups, N. Meningitidis

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