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

    DIMENSION-WBG

    K Number: K863223 · Decision Mar 10, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    400
    Applicant Total
    8
    Review Days
    201

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    Basic Information

    Device Name
    DIMENSION-WBG
    K Number
    K863223
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Dimension Diagnostics
    Date Received
    August 21, 1986
    Decision Date
    March 10, 1987
    Product Code
    CGA
    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
    CGA Glucose Oxidase, Glucose

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    Other Clearances by Dimension Diagnostics

    K Number Device Name
    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
    K844709 CRITIC-ARS