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

    CONTROL SERUMS FOR NONTREPONEMAL TEST

    K Number: K810119 · Decision Feb 9, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    24

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    Basic Information

    Device Name
    CONTROL SERUMS FOR NONTREPONEMAL TEST
    K Number
    K810119
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3820
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Hillside Acres, Inc.
    Date Received
    January 16, 1981
    Decision Date
    February 9, 1981
    Product Code
    GMP
    Advisory Committee
    Microbiology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GMP Antisera, Control For Nontreponemal Tests

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