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

    ANIMAL SERUM PRODUCTS

    K Number: K810478 · Decision Apr 8, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    44
    Applicant Total
    1
    Review Days
    44

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    Basic Information

    Device Name
    ANIMAL SERUM PRODUCTS
    K Number
    K810478
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2800
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Animal Health Laboratories, Inc.
    Date Received
    February 23, 1981
    Decision Date
    April 8, 1981
    Product Code
    KIS
    Advisory Committee
    Hematology
    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
    KIS Sera, Animal And Human

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