Medical Device Manufacturer · US , Mchenry , IL

Kent Laboratories, Inc. - FDA 510(k) Cleared Devices

40 submissions · 37 cleared · Since 1977

Recent clearances: HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT, HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT, HUMAN C1Q RADIAL IMMUNODIFFUSION KIT

40

Total

37

Cleared

0

Denied

FDA 510(k) Regulatory Record - Kent Laboratories, Inc. Immunology ✕

30 devices

1-12 of 30

Cleared Jun 01, 1995

HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT

Immunology · 35d

Cleared May 30, 1995

HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT

Immunology · 33d

Cleared May 30, 1995

HUMAN C1Q RADIAL IMMUNODIFFUSION KIT

Immunology · 33d

Cleared Apr 10, 1995

HUMAN C-5 RADIAL IMMUNODIFFUSION KIT

Immunology · 89d

Cleared Nov 27, 1985

72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2

Immunology · 279d

Cleared Nov 25, 1985

72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL

Immunology · 277d

Cleared Nov 01, 1985

ANTISERUM TO HUMAN PREALBUMIN

Immunology · 253d

Cleared Nov 01, 1985

ANTISERUM TO HUMAN APOLIPOPROTEIN B

Immunology · 253d

Cleared Nov 01, 1985

ANTISERUM TO HUMAN APOLIPOPROTEIN A-I

Immunology · 253d

Cleared Dec 30, 1982

ANTI SERA TO HUMAN OROSCOMUCOID

Immunology · 16d

Cleared Aug 12, 1981

72 DETERMIN. SIZE RADIAL IMMUNOD. TEST

Immunology · 65d

Cleared Sep 12, 1979

ANTISERUM TO RABBIT IGG H & L CHAIN

Immunology · 153d