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

    D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT

    K Number: K081928 · Decision Dec 23, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    22
    Applicant Total
    37
    Review Days
    169

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    Basic Information

    Device Name
    D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT
    K Number
    K081928
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3480
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diagnostic Hybrids, Inc.
    Date Received
    July 7, 2008
    Decision Date
    December 23, 2008
    Product Code
    LKT
    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
    LKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa

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    Other Clearances by Diagnostic Hybrids, Inc.

    K Number Device Name
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    K093415 D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT
    K093233 D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT
    K092882 D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT
    K091171 D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT
    K092300 MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
    K091753 ELVIS HSV ID AND D3 TYPING TEST SYSTEM
    K083391 THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY
    K090073 D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT
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