BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MODIFICATION TO BVBLUE

    K Number: K050755 · Decision Apr 6, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    14

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    Basic Information

    Device Name
    MODIFICATION TO BVBLUE
    K Number
    K050755
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gryphus Diagnostics, LLC
    Date Received
    March 23, 2005
    Decision Date
    April 6, 2005
    Product Code
    MXB
    Advisory Committee
    Microbiology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MXB Test, Vaginal, Bacterial Sialidase

    Similar 510(k) Clearances

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

    BVBLUE

    FDA 510(k)
    FDA Class 1 ·Microbiology
    View all

    Other Clearances by Gryphus Diagnostics, LLC

    K Number Device Name
    K993732 BVBLUE