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

    CYSTIC FIBROSIS TESTING INSTRUMENT

    K Number: K772176 · Decision Dec 20, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    33
    Applicant Total
    1
    Review Days
    29

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    Basic Information

    Device Name
    CYSTIC FIBROSIS TESTING INSTRUMENT
    K Number
    K772176
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2485
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Laboratory Equipment Design Co.
    Date Received
    November 21, 1977
    Decision Date
    December 20, 1977
    Product Code
    JJN
    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
    JJN Apparatus, Electrophoresis, For Clinical Use

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