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

    AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101

    K Number: K072901 · Decision Jul 1, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    264

    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
    AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101
    K Number
    K072901
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Amdl, Inc.
    Date Received
    October 11, 2007
    Decision Date
    July 1, 2008
    Product Code
    NTY
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NTY System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer

    Other Clearances by Amdl, Inc.

    K Number Device Name
    K981396 PYLORIPROBE