BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    RAMP INFLUENZA A/B ASSAY

    K Number: K071591 · Decision Apr 16, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    71
    Applicant Total
    7
    Review Days
    310

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    Basic Information

    Device Name
    RAMP INFLUENZA A/B ASSAY
    K Number
    K071591
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3328
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Response Biomedical Corp.
    Date Received
    June 11, 2007
    Decision Date
    April 16, 2008
    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 Response Biomedical Corp.

    K Number Device Name
    K093116 MODIFICATION TO: RAMP INFLUENZA A/B ASSAY
    K091235 RAMP RSV ASSAY
    K063662 RAMP NT-PROBNP ASSAY
    K033747 RAMP CK-MB ASSAY
    K033745 RAMP TROPONIN I ASSAY
    K012040 RAMP MYOGLOBIN ASSAY