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

    DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151

    K Number: K870467 · Decision Mar 24, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    44
    Applicant Total
    11
    Review Days
    49

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    Basic Information

    Device Name
    DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151
    K Number
    K870467
    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, 1987
    Decision Date
    March 24, 1987
    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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    K884654 ALPHACALF SERUM
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    K880470 BOVINE CALF SERUM CATALOG #A-2119
    K870938 FETAL BOVINE SERUM
    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
    K870468 ADULT BOVINE SERUM
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