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

    ACCESS OSTASE IMMUNOENZYMETRIC ASSAY

    K Number: K994278 · Decision Mar 28, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    25
    Applicant Total
    270
    Review Days
    99

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    Basic Information

    Device Name
    ACCESS OSTASE IMMUNOENZYMETRIC ASSAY
    K Number
    K994278
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    December 20, 1999
    Decision Date
    March 28, 2000
    Product Code
    CIN
    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
    CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

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