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

    Lyme B. burgdorferi (IgG) MarStripe Test

    K Number: K163095 · Decision Feb 1, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    110
    Applicant Total
    5
    Review Days
    89

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Lyme B. burgdorferi (IgG) MarStripe Test
    K Number
    K163095
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3830
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Trinity Biotech
    Date Received
    November 4, 2016
    Decision Date
    February 1, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LSR), ordered by most recent decision date.

    Lyme-ID IgG Test; Bio-ID800

    FDA 510(k)
    FDA Class 2 ·Microbiology

    iDart Lyme IgM ImmunoBlot Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    iDart Lyme IgG ImmunoBlot Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Viramed Borrela All-In-One ViraChip Test Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Trinity Biotech

    K Number Device Name
    K172254 Lyme B. burgdorferi (IgM) MarStripe Test
    K120001 UNIGOLD GIARDIA
    K121565 UNI-GOLD CRYPTOSPORIDIUM
    K083896 DESTINY MAX COAGULATION ANALYZER