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

    Anti-HCV Next

    K Number: K252424 · Decision Apr 28, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    1
    Applicant Total
    883
    Review Days
    270

    Basic Information

    Device Name
    Anti-HCV Next
    K Number
    K252424
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3169
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Laboratories
    Date Received
    August 1, 2025
    Decision Date
    April 28, 2026
    Product Code
    MZO
    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
    MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

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