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

    Solana HSV 1+2/VZV Assay

    K Number: K162451 · Decision Nov 28, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    8
    Applicant Total
    37
    Review Days
    88

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    Basic Information

    Device Name
    Solana HSV 1+2/VZV Assay
    K Number
    K162451
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3309
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quidel Corporation
    Date Received
    September 1, 2016
    Decision Date
    November 28, 2016
    Product Code
    PGI
    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
    PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

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