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

    INPOUCH-TV POUCH

    K Number: K896296 · Decision Jan 29, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    12
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    INPOUCH-TV POUCH
    K Number
    K896296
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Biomed Diagnostics, Inc.
    Date Received
    October 31, 1989
    Decision Date
    January 29, 1990
    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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