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

    MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD

    K Number: K901113 · Decision Mar 29, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    129
    Applicant Total
    14
    Review Days
    22

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    Basic Information

    Device Name
    MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD
    K Number
    K901113
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Verichem Laboratories, Inc.
    Date Received
    March 7, 1990
    Decision Date
    March 29, 1990
    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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    Other Clearances by Verichem Laboratories, Inc.

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    K924904 HDL-CHOLESTEROL STANDARD, MODIFICATION
    K912513 ELECTROLYTE CONTROL
    K882059 BILIRUBIN STANDARD
    K881320 URINE TOXICOLOGY STANDARD
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