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

    HERPESELECT 1 ELISA IGG, MODEL EL0910G

    K Number: K021429 · Decision Jul 29, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    19
    Applicant Total
    5
    Review Days
    87

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    Basic Information

    Device Name
    HERPESELECT 1 ELISA IGG, MODEL EL0910G
    K Number
    K021429
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Focus Technologies, Inc.
    Date Received
    May 3, 2002
    Decision Date
    July 29, 2002
    Product Code
    MXJ
    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
    MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1

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    Other Clearances by Focus Technologies, Inc.

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    K031952 WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M
    K031953 WEST NILE VIRUS ELISA IGG, MODEL EL0300G
    K021486 HERPESELECT 2 ELISA IGG, MODEL ELO920G