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

    Maverick RNP Assay and Maverick Diagnostic System

    K Number: K191085 · Decision Oct 25, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    22
    Applicant Total
    2
    Review Days
    184

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    Basic Information

    Device Name
    Maverick RNP Assay and Maverick Diagnostic System
    K Number
    K191085
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Genalyte, Inc.
    Date Received
    April 24, 2019
    Decision Date
    October 25, 2019
    Product Code
    LKO
    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
    LKO Anti-Rnp Antibody, Antigen And Control

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    Other Clearances by Genalyte, Inc.

    K Number Device Name
    K234091 Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0