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

    IN-VITRO DIAGNOSTIC REAGENT SET

    K Number: K930074 · Decision May 11, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    89
    Applicant Total
    7
    Review Days
    124

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    Basic Information

    Device Name
    IN-VITRO DIAGNOSTIC REAGENT SET
    K Number
    K930074
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1495
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Horizon Diagnostics, Inc.
    Date Received
    January 7, 1993
    Decision Date
    May 11, 1993
    Product Code
    JGJ
    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
    JGJ Photometric Method, Magnesium

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