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

    Acucy Influenza A&B Test with the Acucy System

    K Number: K182001 · Decision Dec 17, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    71
    Applicant Total
    6
    Review Days
    144

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    Basic Information

    Device Name
    Acucy Influenza A&B Test with the Acucy System
    K Number
    K182001
    Device Class
    FDA class 2
    Clearance Type
    Dual Track
    Regulation Number
    866.3328
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SEKISUI Diagnostics, LLC
    Date Received
    July 26, 2018
    Decision Date
    December 17, 2018
    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 SEKISUI Diagnostics, LLC

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    K181436 OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
    K121397 OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT
    K123182 OSOM INFLUENZA A&B TEST MODEL 190