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

    BOVINE CALF SERUM CATALOG #A-2119

    K Number: K880470 · Decision Apr 1, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    44
    Applicant Total
    11
    Review Days
    58

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    Basic Information

    Device Name
    BOVINE CALF SERUM CATALOG #A-2119
    K Number
    K880470
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2800
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Hyclone Laboratories, Inc.
    Date Received
    February 3, 1988
    Decision Date
    April 1, 1988
    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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    Other Clearances by Hyclone Laboratories, Inc.

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    K870467 DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151
    K870469 DEFINED EQUINE SERUM #A-3311
    K870464 CHARACTERIZED FETAL BOVINE SERUM #A-1115
    K870466 DEFINED CALF BOVINE SERUM #A-2111
    K870463 DEFINED FETAL BOVINE SERUM #A-1111
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