BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    QUANTIFY(901)

    K Number: K972710 · Decision Aug 15, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    60
    Applicant Total
    9
    Review Days
    25

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    Basic Information

    Device Name
    QUANTIFY(901)
    K Number
    K972710
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hematronix, Inc.
    Date Received
    July 21, 1997
    Decision Date
    August 15, 1997
    Product Code
    JJW
    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
    JJW Urinalysis Controls (Assayed And Unassayed)

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