BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    LACTOPLATE

    K Number: K852737 · Decision Oct 25, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    120

    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
    LACTOPLATE
    K Number
    K852737
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5570
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Mackeen Consultants, Ltd.
    Date Received
    June 27, 1985
    Decision Date
    October 25, 1985
    Product Code
    DEG
    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
    DEG Lactoferrin, Antigen, Antiserum, Control

    Similar 510(k) Clearances

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

    LEUKO EZ VUE

    FDA 510(k)
    FDA Class 1 ·Immunology

    IBD-SCAN

    FDA 510(k)
    FDA Class 1 ·Immunology

    IBD-QUIK CHEK

    FDA 510(k)
    FDA Class 1 ·Immunology

    IBD-CHEK

    FDA 510(k)
    FDA Class 1 ·Immunology

    LEUKO-TEST

    FDA 510(k)
    FDA Class 1 ·Immunology

    LACTOFERRIN MICROASSAY SYSTEM

    FDA 510(k)
    FDA Class 1 ·Immunology
    View all

    Other Clearances by Mackeen Consultants, Ltd.

    K Number Device Name
    K915062 DOHLMAN DOANE KERATOPROTHESIS