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

    Alere BinaxNOW Influenza A & B Card 2, Alere Reader

    K Number: K181853 · Decision Aug 8, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    71
    Applicant Total
    17
    Review Days
    28

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    Basic Information

    Device Name
    Alere BinaxNOW Influenza A & B Card 2, Alere Reader
    K Number
    K181853
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.3328
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alere Scarborough, Inc.
    Date Received
    July 11, 2018
    Decision Date
    August 8, 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 Alere Scarborough, Inc.

    K Number Device Name
    DEN180014 WOUNDCHEK Bacterial Status
    K190204 ID NOW Influenza A & B 2
    K173653 Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
    K173932 Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2
    K173502 Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
    K171792 Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
    K162642 Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
    K163266 Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument
    K161375 Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit
    K161364 BinaxNOW G6PD Test
    Search all 17 clearances from Alere Scarborough, Inc. →