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

    WONDFO RAPID STREP A TEST

    K Number: K133343 · Decision Jan 31, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    43
    Applicant Total
    43
    Review Days
    93

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    Basic Information

    Device Name
    WONDFO RAPID STREP A TEST
    K Number
    K133343
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3740
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangzhou Wondfo Biotech Co., Ltd.
    Date Received
    October 30, 2013
    Decision Date
    January 31, 2014
    Product Code
    GTY
    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
    GTY Antigens, All Groups, Streptococcus Spp.

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