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

    ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585

    K Number: K061282 · Decision Jun 2, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    244
    Applicant Total
    270
    Review Days
    25

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    Basic Information

    Device Name
    ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585
    K Number
    K061282
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    May 8, 2006
    Decision Date
    June 2, 2006
    Product Code
    JIT
    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
    JIT Calibrator, Secondary

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