BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB

    K Number: K853803 · Decision Oct 15, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    44
    Applicant Total
    1
    Review Days
    34

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    Basic Information

    Device Name
    FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB
    K Number
    K853803
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2800
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Z.L. Bocknek Laboratories, Inc.
    Date Received
    September 11, 1985
    Decision Date
    October 15, 1985
    Product Code
    KIS
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    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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