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

    HEMASTAPH

    K Number: K840553 · Decision Apr 13, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    11
    Applicant Total
    137
    Review Days
    65

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    Basic Information

    Device Name
    HEMASTAPH
    K Number
    K840553
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2160
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Remel Co.
    Date Received
    February 8, 1984
    Decision Date
    April 13, 1984
    Product Code
    JTL
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JTL Plasma, Coagulase, Human, Horse And Rabbit

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