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

    UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD

    K Number: K980525 · Decision Apr 15, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    63

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    Basic Information

    Device Name
    UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD
    K Number
    K980525
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1187
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Marukin Shoyu Co., Ltd.
    Date Received
    February 11, 1998
    Decision Date
    April 15, 1998
    Product Code
    KWX
    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
    KWX Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KWX), ordered by most recent decision date.

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