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

    ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2

    K Number: K220801 · Decision Jun 24, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    19
    Applicant Total
    6
    Review Days
    98

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    Basic Information

    Device Name
    ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
    K Number
    K220801
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.3980
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Diagnostics Scarborough, Inc.
    Date Received
    March 18, 2022
    Decision Date
    June 24, 2022
    Product Code
    OZE
    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
    OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay

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    Other Clearances by Abbott Diagnostics Scarborough, Inc.

    K Number Device Name
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    K232775 ID NOW Influenza A & B 2
    K221925 ID NOW COVID-19 2.0
    K191534 ID NOW Influenza A & B 2