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

    RUBINDEX*DIRECT SYSTEM

    K Number: K781638 · Decision Dec 20, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    10
    Applicant Total
    24
    Review Days
    90

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    Basic Information

    Device Name
    RUBINDEX*DIRECT SYSTEM
    K Number
    K781638
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Ortho Diagnostics, Inc.
    Date Received
    September 21, 1978
    Decision Date
    December 20, 1978
    Product Code
    GOK
    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
    GOK Antisera, Hai (Including Hai Control), Rubella

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