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

    RHODAMINE-CONJUGATED ANTISERUM

    K Number: K771144 · Decision Jul 14, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    40
    Review Days
    17

    Basic Information

    Device Name
    RHODAMINE-CONJUGATED ANTISERUM
    K Number
    K771144
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5520
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    KENT LABORATORIES, INC.
    Date Received
    June 27, 1977
    Decision Date
    July 14, 1977
    Product Code
    DBY
    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
    DBY Fab, Rhodamine, Antigen, Antiserum, Control

    Similar 510(k) Clearances

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

    CONVOY ADVANCED DELIVERY SHEATH

    FDA 510(k)
    FDA Class 1 ·Immunology

    TORFLEX TRANSSEPTAL GUIDING SHEATH

    FDA 510(k)
    FDA Class 1 ·Immunology

    BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER

    FDA 510(k)
    FDA Class 1 ·Immunology

    CONVOY ADVANCED DELIVERY SHEATH KIT

    FDA 510(k)
    FDA Class 1 ·Immunology

    GORE INTRODUCER SHEATH

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

    Other Clearances by KENT LABORATORIES, INC.

    K Number Device Name
    K951966 HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT
    K951967 HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT
    K951968 HUMAN C1Q RADIAL IMMUNODIFFUSION KIT
    K950102 HUMAN C-5 RADIAL IMMUNODIFFUSION KIT
    K850683 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2
    K850682 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL
    K850691 ANTISERUM TO HUMAN APOLIPOPROTEIN A-I
    K850690 ANTISERUM TO HUMAN APOLIPOPROTEIN B
    K850686 ANTISERUM TO HUMAN PREALBUMIN
    K831961 IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN
    Search all 40 clearances from KENT LABORATORIES, INC. →