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

    RUBELISA TEST KIT

    K Number: K780996 · Decision Nov 22, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    8
    Review Days
    162

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    Basic Information

    Device Name
    RUBELISA TEST KIT
    K Number
    K780996
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Microbiological Assoc.
    Date Received
    June 13, 1978
    Decision Date
    November 22, 1978
    Product Code
    GON
    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
    GON Antigen, Cf (Including Cf Control), Rubella

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    Other Clearances by Microbiological Assoc.

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    K781143 IMMUNOFLUORESCENCE TEST KIT
    K770764 TISSUE CULTURE MEDIA W/HEPES BUFFER
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