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

    HDL-CHOLESTEROL STANDARD, MODIFICATION

    K Number: K924904 · Decision Jan 13, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    129
    Applicant Total
    14
    Review Days
    106

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    Basic Information

    Device Name
    HDL-CHOLESTEROL STANDARD, MODIFICATION
    K Number
    K924904
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Verichem Laboratories, Inc.
    Date Received
    September 29, 1992
    Decision Date
    January 13, 1993
    Product Code
    JIS
    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
    JIS Calibrator, Primary

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