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

    ORNITHINE INDOLE MOTILITY

    K Number: K842851 · Decision Aug 7, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    145
    Applicant Total
    7
    Review Days
    18

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    Basic Information

    Device Name
    ORNITHINE INDOLE MOTILITY
    K Number
    K842851
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2320
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Anarobe Systems
    Date Received
    July 20, 1984
    Decision Date
    August 7, 1984
    Product Code
    JSH
    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
    JSH Culture Media, Non-Selective And Differential

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    Other Clearances by Anarobe Systems

    K Number Device Name
    K842850 TRIPLE SUGAR IRON
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    K842855 CHRISTENSEN'S UREA AGAR
    K842849 TRYPTICASE SOY BROTH
    K842853 LYSINE IRON AGAR
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