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

    SEROFAST

    K Number: K903958 · Decision Dec 21, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    115

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    Basic Information

    Device Name
    SEROFAST
    K Number
    K903958
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3375
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Intl. Mycoplasma/Mdc Assoc.
    Date Received
    August 28, 1990
    Decision Date
    December 21, 1990
    Product Code
    GSA
    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
    GSA Antisera, All Mycoplasma Spp.

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