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

    ISOAMP HSV ASSAY

    K Number: K111951 · Decision Sep 27, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    81

    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
    ISOAMP HSV ASSAY
    K Number
    K111951
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biohelix Corporation
    Date Received
    July 8, 2011
    Decision Date
    September 27, 2011
    Product Code
    OQO
    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
    OQO Herpes Simplex Virus Nucleic Acid Amplification Assay

    Similar 510(k) Clearances

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

    Sentosa SA201 HSV 1/2 Qualitative PCR Test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Aptima Herpes Simplex Viruses 1 & 2 Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack

    FDA 510(k)
    FDA Class 2 ·Microbiology

    cobas HSV 1 and 2 Test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SEEGENE ANYPLEX II HSV-1/2 ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    artus HSV-1/2 QS-RGQ MDx Kit

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