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

    CHROMOSTREAK

    K Number: K000718 · Decision Aug 24, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    12
    Applicant Total
    2
    Review Days
    174

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    Basic Information

    Device Name
    CHROMOSTREAK
    K Number
    K000718
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Novamed , Ltd.
    Date Received
    March 3, 2000
    Decision Date
    August 24, 2000
    Product Code
    JSN
    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
    JSN Culture Media, Propagating Transport

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    Other Clearances by Novamed , Ltd.

    K Number Device Name
    K974428 DIPSTREAK