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

    SDL LISTERIA MONOCYTOGENES CONTROL

    K Number: K840503 · Decision Mar 23, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    28
    Review Days
    46

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    Basic Information

    Device Name
    SDL LISTERIA MONOCYTOGENES CONTROL
    K Number
    K840503
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3355
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Scientific Device Laboratory, Inc.
    Date Received
    February 6, 1984
    Decision Date
    March 23, 1984
    Product Code
    GSI
    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
    GSI Antigens, Slide And Tube, All Types, Listeria Monocytogenes

    Other Clearances by Scientific Device Laboratory, Inc.

    K Number Device Name
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    K895848 PRESSURE STEAM STERILIZERS
    K890670 CRYPTOSPORIDIUM CONTROL SLIDE
    K890718 GRAM STAIN CONTROL SLIDE
    K884069 SNAP N' STAIN IODINE STAIN
    K884011 SNAP N' STAIN IRON STAIN
    K883052 METHENO-STAIN KIT
    K881598 SDL TRICHROME STAIN
    Search all 28 clearances from Scientific Device Laboratory, Inc. →