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

    CRITIC-ARS

    K Number: K844709 · Decision Jan 8, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    301
    Applicant Total
    8
    Review Days
    36

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    Basic Information

    Device Name
    CRITIC-ARS
    K Number
    K844709
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Dimension Diagnostics
    Date Received
    December 3, 1984
    Decision Date
    January 8, 1985
    Product Code
    JIX
    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
    JIX Calibrator, Multi-Analyte Mixture

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    Other Clearances by Dimension Diagnostics

    K Number Device Name
    K863223 DIMENSION-WBG
    K861366 ALT-30, 60 AND 100
    K854967 CRITIC - SF, ASSAYED
    K853943 CRITIC C LEVEL I & II
    K852295 UROL-GUANT
    K844848 IMA-TROL IMMUNOASSAY CONTROL
    K844760 UROL-QUAL