BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇳 China

    AllTest Strep A Rapid Test

    K Number: K260342 · Decision Apr 30, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    43
    Applicant Total
    14
    Review Days
    87

    Basic Information

    Device Name
    AllTest Strep A Rapid Test
    K Number
    K260342
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3740
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hangzhou AllTest Biotech Co., Ltd.
    Date Received
    February 2, 2026
    Decision Date
    April 30, 2026
    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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