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

    CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA

    K Number: K964637 · Decision Dec 24, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    110
    Applicant Total
    10
    Review Days
    35

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    Basic Information

    Device Name
    CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA
    K Number
    K964637
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Packaging Corp.
    Date Received
    November 19, 1996
    Decision Date
    December 24, 1996
    Product Code
    JSM
    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
    JSM Culture Media, Non-Propagating Transport

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