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

    CODE-A-WELL SERIES 1-600, 1-625

    K Number: K863374 · Decision Sep 11, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    65
    Applicant Total
    8
    Review Days
    8

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    Basic Information

    Device Name
    CODE-A-WELL SERIES 1-600, 1-625
    K Number
    K863374
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2500
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Plastic Injectors, Inc.
    Date Received
    September 3, 1986
    Decision Date
    September 11, 1986
    Product Code
    JTC
    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
    JTC Device, Microtiter Diluting/Dispensing

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    Other Clearances by Plastic Injectors, Inc.

    K Number Device Name
    K884781 OPTI-POINT
    K863423 CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100
    K844058 CODE-A-WALL SERIES 1-250 INOCULUM TRAY
    K842848 CODE-A-WELL 350 MICROTITRATION STRIPS
    K841632 CODE-A-WELL SERIES 200 PLATE
    K841937 CODE-A-WELL SERIES 300 PLATE
    K841390 CODE-A-WELL