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

    ENZYGNOST PLATELET FACTOR 4 (PF4) KIT

    K Number: K890633 · Decision Apr 21, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    12
    Applicant Total
    145
    Review Days
    72

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    Basic Information

    Device Name
    ENZYGNOST PLATELET FACTOR 4 (PF4) KIT
    K Number
    K890633
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7695
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Behring Diagnostics, Inc.
    Date Received
    February 8, 1989
    Decision Date
    April 21, 1989
    Product Code
    LCO
    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
    LCO Platelet Factor 4 Radioimmunoassay

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