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

    BUFFER, COLLAGEN REAGENT AND DILUENT

    K Number: K781710 · Decision Oct 24, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    11
    Applicant Total
    12
    Review Days
    19

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    Basic Information

    Device Name
    BUFFER, COLLAGEN REAGENT AND DILUENT
    K Number
    K781710
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6675
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Diagnostica, Inc.
    Date Received
    October 5, 1978
    Decision Date
    October 24, 1978
    Product Code
    JBX
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JBX Aggregrometer, Platelet

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