BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Viramed Borrela All-In-One ViraChip Test Kit

    K Number: K220016 · Decision Aug 19, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    110
    Applicant Total
    7
    Review Days
    226

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    Basic Information

    Device Name
    Viramed Borrela All-In-One ViraChip Test Kit
    K Number
    K220016
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3830
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Viramed Biotech AG
    Date Received
    January 5, 2022
    Decision Date
    August 19, 2022
    Product Code
    LSR
    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
    LSR Reagent, Borrelia Serological Reagent

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    Other Clearances by Viramed Biotech AG

    K Number Device Name
    K163695 Borrelia B31 ViraChip IgM Test Kit
    K163504 Borrelia B31 ViraChip IgG Test Kit
    K092693 VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS
    K082329 VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE
    K051071 VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT
    K051169 BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT