Medical Device Manufacturer · US , Mchenry , IL

Kent Laboratories, Inc.

40 submissions · 37 cleared · Since 1977
40
Total
37
Cleared
0
Denied

Kent Laboratories, Inc. — FDA 510(k) Submissions

Kent Laboratories, Inc. has submitted 40 FDA 510(k) premarket notifications since 1977, of which 37 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Igg, Antigen, Antiserum, Control, Igg (fab Fragment Specific), Antigen, Antiserum, Control, Ceruloplasmin, Antigen, Antiserum, Control, Prealbumin, Antigen, Antiserum, Control, Apolipoproteins . Use the specialty filter in the sidebar to narrow results.

40 devices
1–25 of 40
HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT
K951966 · JZJ Prealbumin, Antigen,... · Immunology
Jun 1995 35d
HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT
K951967 · DBA Complement C1 Inhibitor... · Immunology
May 1995 33d
HUMAN C1Q RADIAL IMMUNODIFFUSION KIT
K951968 · DAK Complement C1q, Antigen,... · Immunology
May 1995 33d
HUMAN C-5 RADIAL IMMUNODIFFUSION KIT
K950102 · DAY Complement C5, Antigen,... · Immunology
Apr 1995 89d
72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2
K850683 · DEB Alpha-2-macroglobulin,... · Immunology
Nov 1985 279d
72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL
K850682 · DDB Ceruloplasmin, Antigen,... · Immunology
Nov 1985 277d
ANTISERUM TO HUMAN PREALBUMIN
K850686 · JZJ Prealbumin, Antigen,... · Immunology
Nov 1985 253d
ANTISERUM TO HUMAN APOLIPOPROTEIN B
K850690 · MSJ Apolipoproteins · Immunology
Nov 1985 253d
ANTISERUM TO HUMAN APOLIPOPROTEIN A-I
K850691 · MSJ Apolipoproteins · Immunology
Nov 1985 253d
IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN
K831961 · JBQ Antithrombin Iii... · Chemistry
Aug 1983 55d
RADIAL IMMUNO-TEST FOR HUMAN C-REACTI
K831958 · DCK C-reactive Protein,... · Chemistry
Jul 1983 32d
RADIAL IMMUNO-TEST FOR HUMAN FACTOR B
K831959 · JZH Factor B, Antigen,... · Chemistry
Jul 1983 32d
TEST FOR HUMAN ALPHA ONE ACID GLYCO-
K831960 · LKL Alpha-1-acid-glycoprotein... · Chemistry
Jul 1983 32d
DETERM. SIZE 72 RADIAL-HUMAN IGD
K831956 · CZJ Igd, Antigen, Antiserum,... · Chemistry
Jul 1983 31d
DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB
K831957 · DAD Haptoglobin, Antigen,... · Chemistry
Jul 1983 31d
ANTI SERA TO HUMAN OROSCOMUCOID
K823765 · DEX Alpha-1-b-glycoprotein,... · Immunology
Dec 1982 16d
ANTISERA TO HUMAN FERRITIN
K822472 · DBF Ferritin, Antigen,... · Microbiology
Sep 1982 44d
72 DETERMIN. SIZE RADIAL IMMUNOD. TEST
K811613 · DDG Transferrin, Antigen,... · Immunology
Aug 1981 65d
ANTISERUM TO RABBIT IGG H & L CHAIN
K790706 · DFH Kappa, Antigen,... · Immunology
Sep 1979 153d
ANTISERUM, HUMAN, IGG H & L CHAIN
K790702 · DEW Igg, Antigen, Antiserum,... · Immunology
Sep 1979 145d
ANTISERA TO HUMAN FRAGMENT
K790711 · DFK Igg (fab Fragment... · Immunology
Sep 1979 145d
ANTISERUM TO HUMAN HEMOPEXIN
K790713 · CZX Hemopexin, Antigen,... · Immunology
Sep 1979 145d
ANTISERUM TO HUMAN IG G FC FRAGMENTS
K790708 · DAS Igg (fc Fragment... · Immunology
Aug 1979 132d
ANTISERUM TO RABBIT IMMUNOGLOBULIN
K790709 · DFZ Igg (gamma Chain... · Immunology
Aug 1979 126d
ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULI
K790712 · DDB Ceruloplasmin, Antigen,... · Immunology
Aug 1979 126d
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