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

    Borrelia B31 ViraChip IgM Test Kit

    K Number: K163695 · Decision Aug 22, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    110
    Applicant Total
    7
    Review Days
    237

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    Basic Information

    Device Name
    Borrelia B31 ViraChip IgM Test Kit
    K Number
    K163695
    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
    December 28, 2016
    Decision Date
    August 22, 2017
    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
    K220016 Viramed Borrela All-In-One ViraChip 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