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

    Nova Max Creat eGFR Monitoring System

    K Number: K251281 · Decision Jan 21, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    40
    Review Days
    272

    Basic Information

    Device Name
    Nova Max Creat eGFR Monitoring System
    K Number
    K251281
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1225
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nova Biomedical Corporation
    Date Received
    April 24, 2025
    Decision Date
    January 21, 2026
    Product Code
    SHB
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SHB Creatinine Test System For At Home Prescription Use

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