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

    SMI DIGITRON

    K Number: K840186 · Decision Apr 5, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    93
    Registration Numbers
    93
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    78

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    Basic Information

    Device Name
    SMI DIGITRON
    K Number
    K840186
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Scientific Manufacturing Industries
    Date Received
    January 18, 1984
    Decision Date
    April 5, 1984
    Product Code
    JRC
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JRC Micro Pipette

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    Other Clearances by Scientific Manufacturing Industries

    K Number Device Name
    K801145 SMI MULTI-TUBE VORTEXER