BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    POLYSTYRENE MICROTITER WELL IMMUNOSOR

    K Number: K832345 · Decision Nov 25, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    113
    Applicant Total
    10
    Review Days
    130

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    Basic Information

    Device Name
    POLYSTYRENE MICROTITER WELL IMMUNOSOR
    K Number
    K832345
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Reagent Tech.
    Date Received
    July 18, 1983
    Decision Date
    November 25, 1983
    Product Code
    DGC
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DGC Ige, Antigen, Antiserum, Control

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    Other Clearances by Diagnostic Reagent Tech.

    K Number Device Name
    K843302 NEW ALLERG. COATED MICROFILTER WELL STRI
    K832344 POLYSTYRENE MICROTITER PLATE IMMUNO-
    K831984 POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE
    K831496 ALLERGEN IMMUNOSORBENTS IP SPECIFIC E
    K831774 LOGIPE A DATA REDUCSYSTEM IP SPECIFIC-
    K830005 IP SPECIFIC G
    K830653 POLYSTYRENE MICROTITER PLATE IMMUNOSORB
    K830495 POLYSTYRENE MICROTITER PLATE IMMUNOSOR
    K821094 IP SPECIFIC E