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

    STREP B OIA

    K Number: K991828 · Decision Aug 19, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    43
    Applicant Total
    6
    Review Days
    83

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    Basic Information

    Device Name
    STREP B OIA
    K Number
    K991828
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3740
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biostar, Inc.
    Date Received
    May 28, 1999
    Decision Date
    August 19, 1999
    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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    Other Clearances by Biostar, Inc.

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