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

    BIOTEL (TM)/ DIABETES

    K Number: K855239 · Decision Jun 13, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    80
    Applicant Total
    39
    Review Days
    164

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    Basic Information

    Device Name
    BIOTEL (TM)/ DIABETES
    K Number
    K855239
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1340
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    American Diagnostic Corp.
    Date Received
    December 31, 1985
    Decision Date
    June 13, 1986
    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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