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

    J&S MEDICAL SENTRY URINE DIPSTICK CONTROL

    K Number: K022085 · Decision Jul 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    60
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    J&S MEDICAL SENTRY URINE DIPSTICK CONTROL
    K Number
    K022085
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    J & S Medical Assoc., Inc.
    Date Received
    June 27, 2002
    Decision Date
    July 25, 2002
    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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