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

    SMI MULTI-TUBE VORTEXER

    K Number: K801145 · Decision Jun 9, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    27

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    Basic Information

    Device Name
    SMI MULTI-TUBE VORTEXER
    K Number
    K801145
    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
    May 13, 1980
    Decision Date
    June 9, 1980
    Product Code
    JRQ
    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
    JRQ Shaker/Stirrer

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    Other Clearances by Scientific Manufacturing Industries

    K Number Device Name
    K840186 SMI DIGITRON