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

    AUTOBEAD THYROID UPTAKE

    K Number: K930689 · Decision Nov 10, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    37
    Applicant Total
    5
    Review Days
    273

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    Basic Information

    Device Name
    AUTOBEAD THYROID UPTAKE
    K Number
    K930689
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2560
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bio-Chem Laboratory Systems, Inc.
    Date Received
    February 10, 1993
    Decision Date
    November 10, 1993
    Product Code
    KHO
    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
    KHO Fluorometer, For Clinical Use

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