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

    BIOSCAN REAGENT STRIPS

    K Number: K940043 · Decision Apr 12, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    80
    Applicant Total
    2
    Review Days
    97

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    Basic Information

    Device Name
    BIOSCAN REAGENT STRIPS
    K Number
    K940043
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1340
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bioscan Instruments, Inc.
    Date Received
    January 5, 1994
    Decision Date
    April 12, 1994
    Product Code
    JIL
    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
    JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

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    Other Clearances by Bioscan Instruments, Inc.

    K Number Device Name
    K875248 BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS