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

    AB FLU OIA

    K Number: K981651 · Decision Nov 25, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    71
    Applicant Total
    6
    Review Days
    198

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    Basic Information

    Device Name
    AB FLU OIA
    K Number
    K981651
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3328
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biostar, Inc.
    Date Received
    May 11, 1998
    Decision Date
    November 25, 1998
    Product Code
    PSZ
    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
    PSZ Devices Detecting Influenza A, B, And C Virus Antigens

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    Other Clearances by Biostar, Inc.

    K Number Device Name
    K991829 CDTOX A OIA
    K991828 STREP B OIA
    K962060 STREP A OIA MAX
    K951010 CHLAMYDIA OIA
    K936112 STREP B OIA