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    FDA 510(k), K911590, IMMUNOWELL BORRELIA (LYME)TEST

    FDA 510(k), K911590, IMMUNOWELL BORRELIA (LYME)TEST

    $302.83 USD
    $302.83 USD
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    510(K) Number: K911590
    Device Name: IMMUNOWELL BORRELIA (LYME)TEST
    Manufacturer: GENERAL BIOMETRICS, INC.
    Device Classification Name: reagent, borrelia serological reagent
    Regulation Number: 866.3830
    Classification Product Code: LSR
    Date Received: 04/09/1991
    Decision Date: 12/20/1991
    Regulation Medical Specialty: Microbiology

    Total pages: 230
    Fully redacted pages: 125
    Content pages: 105
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