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

    ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit

    K Number: DEN160025 · Decision Aug 18, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    3
    Review Days
    417

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    Basic Information

    Device Name
    ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit
    K Number
    DEN160025
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.3367
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Id-Fish Technology, Inc.
    Date Received
    June 27, 2016
    Decision Date
    August 18, 2017
    Product Code
    PYN
    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
    PYN Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.

    Other Clearances by Id-Fish Technology, Inc.

    K Number Device Name
    K242872 iDart Lyme IgM ImmunoBlot Kit
    K233367 iDart Lyme IgG ImmunoBlot Kit