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

    ProNephro AKI™ (NGAL)

    K Number: K232761 · Decision Dec 7, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    90

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ProNephro AKI™ (NGAL)
    K Number
    K232761
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1220
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bioporto Diagnostic, Inc.
    Date Received
    September 8, 2023
    Decision Date
    December 7, 2023
    Product Code
    PIG
    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
    PIG Acute Kidney Injury Test System

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PIG), ordered by most recent decision date.

    VIDAS NEPHROCHECK

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NEPHROCHECK Test System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NEPHROCHECK TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all