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

    REPTILASE-R HA35

    K Number: K840210 · Decision Apr 23, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    6
    Applicant Total
    28
    Review Days
    95

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    Basic Information

    Device Name
    REPTILASE-R HA35
    K Number
    K840210
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8100
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Wellcome Diagnostics
    Date Received
    January 19, 1984
    Decision Date
    April 23, 1984
    Product Code
    JCO
    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
    JCO Bothrops Atrox Reagent

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