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

    QUIK-DOT TOXOPLASMOSIS

    K Number: K890048 · Decision Jun 9, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    15
    Review Days
    154

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    Basic Information

    Device Name
    QUIK-DOT TOXOPLASMOSIS
    K Number
    K890048
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Ampcor, Inc.
    Date Received
    January 6, 1989
    Decision Date
    June 9, 1989
    Product Code
    LLA
    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
    LLA Direct Agglutination Test, Toxoplasma Gondii

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    K884750 GROUP A STREP, BETA-STREP
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