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

    PGUA-INDOL MICROTUBE

    K Number: K812467 · Decision Sep 14, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    52
    Applicant Total
    6
    Review Days
    14

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    Basic Information

    Device Name
    PGUA-INDOL MICROTUBE
    K Number
    K812467
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2320
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Carr Microbiologicals
    Date Received
    August 31, 1981
    Decision Date
    September 14, 1981
    Product Code
    JSE
    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
    JSE Culture Media, Multiple Biochemical Test

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    Other Clearances by Carr Microbiologicals

    K Number Device Name
    K812470 HIPP MICROTUBE
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    K812465 PHOS MICROTUBES
    K812468 PYRR MICROTUBE
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