BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇱 Israel

    DIPSTREAK

    K Number: K974428 · Decision Jul 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    284
    Applicant Total
    2
    Review Days
    248

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    Basic Information

    Device Name
    DIPSTREAK
    K Number
    K974428
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2360
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Novamed , Ltd.
    Date Received
    November 24, 1997
    Decision Date
    July 30, 1998
    Product Code
    JSI
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JSI Culture Media, Selective And Differential

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    Other Clearances by Novamed , Ltd.

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